RecallDepth

HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.

Company
Ethicon Endo-Surgery Inc
Recall Initiated
September 23, 2015
Posted
November 16, 2015
Terminated
November 1, 2016
Recall Number
Z-0278-2016
Quantity
441,490 pieces
Firm Location
Blue Ash, OH

Reason for Recall

Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.

Distribution

Distributed US (nationwide) including the District of Columbia & Puerto Rico and in the countries of ARUBA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, ECUADOR, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, MEXICO, PANAMA, PERU, PHILIPPINES, SINGAPORE, SINGAPORE, THAILAND, TAIWAN & VIETNAM.

Lot / Code Info

Model # HARH23: Batch # L90K2V, Exp Date 2019-02; Batch # L90K2W, Exp Date 2019-02; Batch # L90K2X, Exp Date 2019-02; Batch # L90V6P, Exp Date 2019-03; Batch #, L9109W, Exp Date, 2019-03; Batch #, L91739, Exp Date, 2019-04; Batch #, L91F3X, Exp Date, 2019-05; Batch #, L91H6F, Exp Date, 2019-05; Batch #, L91M6D, Exp Date, 2019-06; Batch #, L91W4Z, Exp Date, 2019-06; Batch #, L91Z2W, Exp Date, 2019-07; Batch #, L92002, Exp Date, 2019-07; Batch #, L9214D, Exp Date, 2019-07; Batch #, L92194, Exp Date, 2019-07; Batch #, L92673, Exp Date, 2019-08; Batch #, L92E3H, Exp Date, 2019-08; Batch #, L92G7W, Exp Date, 2019-09; Batch #, L92L5R, Exp Date, 2019-09; Batch #, L92L8T, Exp Date, 2019-09; Batch #, L92R3H, Exp Date, 2019-09; Batch #, L92U7M, Exp Date, 2019-10; Batch #, L92W9M, Exp Date, 2019-10; Batch #, L92Y2K, Exp Date, 2019-10; Batch #, L92Y5M, Exp Date, 2019-10; Batch #, L92Z3M, Exp Date, 2019-10; Batch #, L9361Y, Exp Date, 2019-11; Batch #, M9013T, Exp Date, 2019-12; Batch #, M90214, Exp Date, 2019-12; Batch #, M9029F, Exp Date, 2019-12; Batch #, M9041P, Exp Date, 2019-12; Batch #, M90550, Exp Date, 2019-12; Batch #, M90681, Exp Date, 2019-12; Batch #, M9094Y, Exp Date, 2019-12; Batch #, M90H4Y, Exp Date, 2020-01; Batch #, M90K10, Exp Date, 2020-01; Batch #, M90L6V, Exp Date, 2020-02; Batch #, M90N41, Exp Date, 2020-02; Batch #, M90U2V, Exp Date, 2020-02; Batch #, M90X1T, Exp Date, 2020-02; Batch #, M90Y5Y, Exp Date, 2020-02; Batch #, M9107H, Exp Date, 2020-03; Batch #, M9134X, Exp Date, 2020-03; Batch #, M9159T, Exp Date, 2020-03; Batch #, M91788, Exp Date, 2020-03; Batch #, M9180C, Exp Date, 2020-03; Batch #, M91D2P, Exp Date, 2020-04; Batch #, M91D7P, Exp Date, 2020-04; Batch #, M91E14, Exp Date, 2020-04; Batch #, M91J5X, Exp Date, 2020-04; Batch #, M91L28, Exp Date, 2020-05; Batch #, M91M8D, Exp Date, 2020-05; Batch #, M91P44, Exp Date, 2020-05; Batch #, M91P5A, Exp Date, 2020-05; Batch #, M91T75, Exp Date, 2020-05; Batch #, M91W2T, Exp Date, 2020-05; Batch #, M91W5C, Exp Date, 2020-05; Batch #, M91X4J, Exp Date, 2020-05; Batch #, M91X9A, Exp Date, 2020-06; Batch #, M91X9U, Exp Date, 2020-06; Batch #, M92303, Exp Date, 2020-06; Batch #, M9232T, Exp Date, 2020-06; Batch #, M9237E, Exp Date, 2020-06; Batch #, M9243M, Exp Date, 2020-06; Batch #, M9244V, Exp Date, 2020-06; Batch #, M92795, Exp Date, 2020-07; Batch #, M9283L, Exp Date, 2020-07; Batch #, M9294A, Exp Date, 2020-07; Batch #, M92961, Exp Date, 2020-07; Batch #, M92C66, Exp Date, 2020-07; Batch #, M92C90, Exp Date, 2020-07; Batch #, M92E9X, Exp Date, 2020-07; Batch #, M92G56, Exp Date, 2020-07; Batch #, M92G79, Exp Date, 2020-07; Batch #, M92J3C, Exp Date, 2020-08; Batch #, M92L92, Exp Date, 2020-08 & Batch #, M92N00, Exp Date, 2020-08.  Model # HARH36: Batch #, L90K4P, Exp Date, 2019-02; Batch #, L90W33, Exp Date, 2019-03; Batch #, L90W7K, Exp Date, 2019-03; Batch #, L91023, Exp Date, 2019-03; Batch #, L9103T, Exp Date, 2019-03; Batch #, L91080, Exp Date, 2019-03; Batch #, L9110Z, Exp Date, 2019-03; Batch #, L91144, Exp Date, 2019-03; Batch #, L9124Z, Exp Date, 2019-04; Batch #, L9128A, Exp Date, 2019-04; Batch #, L9131N, Exp Date, 2019-04; Batch #, L9138J, Exp Date, 2019-04; Batch #, L9142T, Exp Date, 2019-04; Batch #, L91467, Exp Date, 2019-04; Batch #, L9150V, Exp Date, 2019-04; Batch #, L91562, Exp Date, 2019-04; Batch #, L91884, Exp Date, 2019-04; Batch #, L9191F, Exp Date, 2019-04; Batch #, L91D1W, Exp Date, 2019-05; Batch #, L91D3V, Exp Date, 2019-05; Batch #, L91E0Y, Exp Date, 2019-05; Batch #, L91E5M, Exp Date, 2019-05; Batch #, L91E8N, Exp Date, 2019-05; Batch #, L91H0G, Exp Date, 2019-05; Batch #, L91H9R, Exp Date, 2019-05; Batch #, L91J2N, Exp Date, 2019-05; Batch #, L91K6G, Exp Date, 2019-05; Batch #, L91L6M, Exp Date, 2019-05; Batch #, L91P2Z, Exp Date, 2019-06; Batch #, L91P5D, Exp Date, 2019-06; Batch #, L91P99, Exp Date, 2019-06; Batch #, L91T2H, Exp Date, 2019-06; Batch #, L91T7E, Exp Date, 2019-06; Batch #, L91T9U, Exp Date, 2019-06; Batch #, L91V2X, Exp Date, 2019-06; Batch #, L91V62, Exp Date, 2019-06; Batch #, L91W1T, Exp Date, 2019-06; Batch #, L91X5P, Exp Date, 2019-07; Batch #, L91Y0X, Exp Date, 2019-07; Batch #, L91Y8W, Exp Date, 2019-07; Batch #, L91Z0N, Exp Date, 2019-07; Batch #, L9204R, Exp Date, 2019-07; Batch #, L92092, Exp Date, 2019-07; Batch #, L9225Y, Exp Date, 2019-07; Batch #, L9232V, Exp Date, 2019-07; Batch #, L9238R, Exp Date, 2019-07; Batch #, L9244H, Exp Date, 2019-07; Batch #, L92524, Exp Date, 2019-07; Batch #, L9255U, Exp Date, 2019-08; Batch #, L9259G, Exp Date, 2019-08; Batch #, L9272N, Exp Date, 2019-08; Batch #, L9284X, Exp Date, 2019-08; Batch #, L9285V, Exp Date, 2019-08; Batch #, L9290A, Exp Date, 2019-08; Batch #, L92921, Exp Date, 2019-08; Batch #, L92952, Exp Date, 2019-08; Batch #, L92987, Exp Date, 2019-08; Batch #, L92A89, Exp Date, 2019-08; Batch #, L92C3L, Exp Date, 2019-08; Batch #, L92C57, Exp Date, 2019-08; Batch #, L92D3K, Exp Date, 2019-08; Batch #, L92D4D, Exp Date, 2019-08; Batch #, L92D9H, Exp Date, 2019-08; Batch #, L92E43, Exp Date, 2019-08; Batch #, L92E8A, Exp Date, 2019-08; Batch #, L92F0U, Exp Date, 2019-08; Batch #, L92F2W, Exp Date, 2019-08; Batch #, L92F5A, Exp Date, 2019-09; Batch #, L92G2F, Exp Date, 2019-09; Batch #, L92G4R, Exp Date, 2019-09; Batch #, L92G9M, Exp Date, 2019-09; Batch #, L92J1A, Exp Date, 2019-09; Batch #, L92J1K, Exp Date, 2019-09; Batch #, L92K1F, Exp Date, 2019-09; Batch #, L92K66, Exp Date, 2019-09; Batch #, L92K9X, Exp Date, 2019-09; Batch #, L92P2A, Exp Date, 2019-09; Batch #, L92P4K, Exp Date, 2019-09; Batch #, L92P5A, Exp Date, 2019-09; Batch #, L92R16, Exp Date, 2019-09; Batch #, L92R2M, Exp Date, 2019-09; Batch #, L92R79, Exp Date, 2019-09; Batch #, L92R95, Exp Date, 2019-09; Batch #, L92T2A, Exp Date, 2019-10; Batch #, L92T64, Exp Date, 2019-10; Batch #, L92T6X, Exp Date, 2019-10; Batch #, L92U09, Exp Date, 2019-10; Batch #, L92U51, Exp Date, 2019-10; Batch #, L92U5K, Exp Date, 2019-10; Batch #, L92V39, Exp Date, 2019-10; Batch #, L92V4E, Exp Date, 2019-10; Batch #, L92V89, Exp Date, 2019-10; Batch #, L92W83, Exp Date, 2019-10; Batch #, L92X1Z, Exp Date, 2019-10; Batch #, L92X5D, Exp Date, 2019-10; Batch #, L92X73, Exp Date, 2019-10; Batch #, L92Y5D, Exp Date, 2019-10; Batch #, L92Y9L, Exp Date, 2019-10; Batch #, L92Z0W, Exp Date, 2019-10; Batch #, L92Z1R, Exp Date, 2019-10; Batch #, L92Z7H, Exp Date, 2019-10; Batch #, L9302N, Exp Date, 2019-10; Batch #, L9307C, Exp Date, 2019-10; Batch #, L93086, Exp Date, 2019-10; Batch #, L9311H, Exp Date, 2019-10; Batch #, L93122, Exp Date, 2019-10; Batch #, L93196, Exp Date, 2019-11; Batch #, L93200, Exp Date, 2019-11; Batch #, L9325A, Exp Date, 2019-11; Batch #, L9327J, Exp Date, 2019-11; Batch #, L93280, Exp Date, 2019-11; Batch #, L9330R, Exp Date, 2019-11; Batch #, L9330W, Exp Date, 2019-11; Batch #, L9333C, Exp Date, 2019-11; Batch #, L9334R, Exp Date, 2019-11; Batch #, L9338D, Exp Date, 2019-11; Batch #, L9339Z, Exp Date, 2019-11; Batch #, L9343C, Exp Date, 2019-11; Batch #, L9347A, Exp Date, 2019-11; Batch #, L9348U, Exp Date, 2019-11; Batch #, L9352A, Exp Date, 2019-11; Batch #, L9353X, Exp Date, 2019-11; Batch #, L9353Y, Exp Date, 2019-11; Batch #, L9356M, Exp Date, 2019-11; Batch #, L9361E, Exp Date, 2019-11; Batch #, L9362R, Exp Date, 2019-11; Batch #, L9362Z, Exp Date, 2019-11; Batch #, L9364G, Exp Date, 2019-11; Batch #, M9002F, Exp Date, 2019-12; Batch #, M9004D, Exp Date, 2019-12; Batch #, M9004N, Exp Date, 2019-12; Batch #, M9016Y, Exp Date, 2019-12; Batch #, M9017T, Exp Date, 2019-12; Batch #, M90235, Exp Date, 2019-12; Batch #, M90275, Exp Date, 2019-12; Batch #, M9027Z, Exp Date, 2019-12; Batch #, M9030P, Exp Date, 2019-12; Batch #, M9038T, Exp Date, 2019-12; Batch #, M90444, Exp Date, 2019-12; Batch #, M9046H, Exp Date, 2019-12; Batch #, M90494, Exp Date, 2019-12; Batch #, M9051C, Exp Date, 2019-12; Batch #, M9057H, Exp Date, 2019-12; Batch #, M90601, Exp Date, 2019-12; Batch #, M9064E, Exp Date, 2019-12; Batch #, M9069Y, Exp Date, 2019-12; Batch #, M9071X, Exp Date, 2019-12; Batch #, M90764, Exp Date, 2019-12; Batch #, M9083G, Exp Date, 2019-12; Batch #, M90880, Exp Date, 2019-12; Batch #, M90902, Exp Date, 2019-12; Batch #, M9091P, Exp Date, 2019-12; Batch #, M9097G, Exp Date, 2019-12; Batch #, M90A5M, Exp Date, 2020-01; Batch #, M90A8A, Exp Date, 2020-01; Batch #, M90C39, Exp Date, 2020-01; Batch #, M90C87, Exp Date, 2020-01; Batch #, M90C88, Exp Date, 2020-01; Batch #, M90C89, Exp Date, 2020-01; Batch #, M90D1E, Exp Date, 2020-01; Batch #, M90D8J, Exp Date, 2020-01; Batch #, M90D9T, Exp Date, 2020-01; Batch #, M90E1U, Exp Date, 2020-01; Batch #, M90F06, Exp Date, 2020-01; Batch #, M90F1W, Exp Date, 2020-01; Batch #, M90F3K, Exp Date, 2020-01; Batch #, M90F5Y, Exp Date, 2020-01; Batch #, M90G00, Exp Date, 2020-01; Batch #, M90G2Y, Exp Date, 2020-01; Batch #, M90G78, Exp Date, 2020-01; Batch #, M90G7Y, Exp Date, 2020-01; Batch #, M90H28, Exp Date, 2020-01; Batch #, M90H7D, Exp Date, 2020-01; Batch #, M90H7E, Exp Date, 2020-01; Batch #, M90H84, Exp Date, 2020-01; Batch #, M90J09, Exp Date, 2020-01; Batch #, M90J6R, Exp Date, 2020-01; Batch #, M90J7R, Exp Date, 2020-01; Batch #, M90K0A, Exp Date, 2020-01; Batch #, M90K5F, Exp Date, 2020-01; Batch #, M90K7A, Exp Date, 2020-01; Batch #, M90K8X, Exp Date, 2020-01; Batch #, M90L1F, Exp Date, 2020-02; Batch #, M90L2K, Exp Date, 2020-02; Batch #, M90L3Z, Exp Date, 2020-02; Batch #, M90L6U, Exp Date, 2020-02; Batch #, M90M34, Exp Date, 2020-02; Batch #, M90M52, Exp Date, 2020-02; Batch #, M90N1M, Exp Date, 2020-02; Batch #, M90N4Z, Exp Date, 2020-02; Batch #, M90N7V, Exp Date, 2020-02  , Batch #, M90P2U, Exp Date, 2020-02; Batch #, M90P5J, Exp Date, 2020-02; Batch #, M90P7K, Exp Date, 2020-02; Batch #, M90R0A, Exp Date, 2020-02; Batch #, M90R2M, Exp Date, 2020-02; Batch #, M90R2N, Exp Date, 2020-02; Batch #, M90R4W, Exp Date, 2020-02; Batch #, M90R7W, Exp Date, 2020-02; Batch #, M90T1J, Exp Date, 2020-02; Batch #, M90T73, Exp Date, 2020-02; Batch #, M90T98, Exp Date, 2020-02; Batch #, M90U35, Exp Date, 2020-02; Batch #, M90U7F, Exp Date, 2020-02; Batch #, M90V0Y, Exp Date, 2020-02; Batch #, M90V32, Exp Date, 2020-02; Batch #, M90V5R, Exp Date, 2020-02; Batch #, M90V91, Exp Date, 2020-02; Batch #, M90W3V, Exp Date, 2020-02; Batch #, M90W6F, Exp Date, 2020-02; Batch #, M90W9J, Exp Date, 2020-02; Batch #, M90X29, Exp Date, 2020-02; Batch #, M90X4P, Exp Date, 2020-02; Batch #, M90X7D, Exp Date, 2020-02; Batch #, M90Y2N, Exp Date, 2020-02; Batch #, M90Y3U, Exp Date, 2020-02; Batch #, M90Y6R, Exp Date, 2020-02; Batch #, M90Y7Z, Exp Date, 2020-03; Batch #, M90Y9P, Exp Date, 2020-03; Batch #, M90Z7K, Exp Date, 2020-03; Batch #, M9100N, Exp Date, 2020-03; Batch #, M9101R, Exp Date, 2020-03; Batch #, M9103R, Exp Date, 2020-03; Batch #, M91110, Exp Date, 2020-03; Batch #, M9111J, Exp Date, 2020-03; Batch #, M9113E, Exp Date, 2020-03; Batch #, M9115C, Exp Date, 2020-03; Batch #, M9117X, Exp Date, 2020-03; Batch #, M91206, Exp Date, 2020-03; Batch #, M9122P, Exp Date, 2020-03; Batch #, M9124V, Exp Date, 2020-03; Batch #, M9127U, Exp Date, 2020-03; Batch #, M9129X, Exp Date, 2020-03; Batch #, M9132N, Exp Date, 2020-03; Batch #, M9134W, Exp Date, 2020-03; Batch #, M91398, Exp Date, 2020-03; Batch #, M9141W, Exp Date, 2020-03; Batch #, M9143P, Exp Date, 2020-03; Batch #, M9145E, Exp Date, 2020-03; Batch #, M9152A, Exp Date, 2020-03; Batch #, M9155F, Exp Date, 2020-03; Batch #, M9155G, Exp Date, 2020-03; Batch #, M9161E, Exp Date, 2020-03; Batch #, M9162M, Exp Date, 2020-03; Batch #, M9168V, Exp Date, 2020-03; Batch #, M91713, Exp Date, 2020-03; Batch #, M9172G, Exp Date, 2020-03; Batch #, M9176J, Exp Date, 2020-03; Batch #, M9180D, Exp Date, 2020-03; Batch #, M9180E, Exp Date, 2020-03; Batch #, M91848, Exp Date, 2020-04; Batch #, M91874, Exp Date, 2020-04; Batch #, M91897, Exp Date, 2020-04; Batch #, M91918, Exp Date, 2020-04; Batch #, M91950, Exp Date, 2020-04; Batch #, M91A06, Exp Date, 2020-04; Batch #, M91A3L, Exp Date, 2020-04; Batch #, M91C5U, Exp Date, 2020-04; Batch #, M91C8D, Exp Date, 2020-04; Batch #, M91D6Y, Exp Date, 2020-04; Batch #, M91D8F, Exp Date, 2020-04; Batch #, M91D8P, Exp Date, 2020-04; Batch #, M91E35, Exp Date, 2020-04; Batch #, M91E71, Exp Date, 2020-04; Batch #, M91E8E, Exp Date, 2020-04; Batch #, M91F2E, Exp Date, 2020-04; Batch #, M91F5D, Exp Date, 2020-04; Batch #, M91F88, Exp Date, 2020-04; Batch #, M91G2U, Exp Date, 2020-04; Batch #, M91G35, Exp Date, 2020-04; Batch #, M91G3Z, Exp Date, 2020-04; Batch #, M91G85, Exp Date, 2020-04; Batch #, M91H3F, Exp Date, 2020-04; Batch #, M91H6F, Exp Date, 2020-04; Batch #, M91H9G, Exp Date, 2020-04; Batch #, M91H9H, Exp Date, 2020-04; Batch #, M91J6A, Exp Date, 2020-04; Batch #, M91J7U, Exp Date, 2020-04; Batch #, M91J9U, Exp Date, 2020-04; Batch #, M91J9Y, Exp Date, 2020-04; Batch #, M91J9Z, Exp Date, 2020-04; Batch #, M91K5T, Exp Date, 2020-05; Batch #, M91L4L, Exp Date, 2020-05; Batch #, M91L4R, Exp Date, 2020-05; Batch #, M91L6V, Exp Date, 2020-05; Batch #, M91M03, Exp Date, 2020-05; Batch #, M91M06, Exp Date, 2020-05; Batch #, M91M1Y, Exp Date, 2020-05; Batch #, M91M29, Exp Date, 2020-05; Batch #, M91M35, Exp Date, 2020-05; Batch #, M91M5Z, Exp Date, 2020-05; Batch #, M91M7M, Exp Date, 2020-05; Batch #, M91N0N, Exp Date, 2020-05; Batch #, M91N15, Exp Date, 2020-05; Batch #, M91N2N, Exp Date, 2020-05; Batch #, M91N2P, Exp Date, 2020-05; Batch #, M91N2T, Exp Date, 2020-05; Batch #, M91N6Z, Exp Date, 2020-05; Batch #, M91N9G, Exp Date, 2020-05; Batch #, M91P2C, Exp Date, 2020-05; Batch #, M91P2D, Exp Date, 2020-05; Batch #, M91P8K, Exp Date, 2020-05; Batch #, M91P91, Exp Date, 2020-05; Batch #, M91R04, Exp Date, 2020-05; Batch #, M91R8A, Exp Date, 2020-05; Batch #, M91R8C, Exp Date, 2020-05; Batch #, M91R94, Exp Date, 2020-05; Batch #, M91T18, Exp Date, 2020-05; Batch #, M91T1N, Exp Date, 2020-05; Batch #, M91T2C, Exp Date, 2020-05; Batch #, M91T2M, Exp Date, 2020-05; Batch #, M91T41, Exp Date, 2020-05; Batch #, M91T7A, Exp Date, 2020-05; Batch #, M91T8F, Exp Date, 2020-05; Batch #, M91U2N, Exp Date, 2020-05; Batch #, M91U46, Exp Date, 2020-05; Batch #, M91U72, Exp Date, 2020-05; Batch #, M91U77, Exp Date, 2020-05; Batch #, M91U80, Exp Date, 2020-05; Batch #, M91U8C, Exp Date, 2020-05; Batch #, M91V2E, Exp Date, 2020-05; Batch #, M91V5J, Exp Date, 2020-05; Batch #, M91V72, Exp Date, 2020-05; Batch #, M91V7W, Exp Date, 2020-05; Batch #, M91V80, Exp Date, 2020-05; Batch #, M91W0E, Exp Date, 2020-05; Batch #, M91W38, Exp Date, 2020-05; Batch #, M91W5F, Exp Date, 2020-05; Batch #, M91W88, Exp Date, 2020-05; Batch #, M91W90, Exp Date, 2020-05; Batch #, M91X06, Exp Date, 2020-05; Batch #, M91X32, Exp Date, 2020-05; Batch #, M91X4F, Exp Date, 2020-05; Batch #, M91X4H, Exp Date, 2020-05; Batch #, M91X4K, Exp Date, 2020-05; Batch #, M91X6K, Exp Date, 2020-05; Batch #, M91X7Y, Exp Date, 2020-06; Batch #, M91Y2G, Exp Date, 2020-06; Batch #, M91Y3C, Exp Date, 2020-06; Batch #, M91Y71, Exp Date, 2020-06; Batch #, M91Y8T, Exp Date, 2020-06; Batch #, M91Z0X, Exp Date, 2020-06; Batch #, M91Z23, Exp Date, 2020-06; Batch #, M91Z39, Exp Date, 2020-06; Batch #, M91Z5E, Exp Date, 2020-06; Batch #, M91Z65, Exp Date, 2020-06; Batch #, M92015, Exp Date, 2020-06; Batch #, M9201W, Exp Date, 2020-06; Batch #, M9204A, Exp Date, 2020-06; Batch #, M9204C, Exp Date, 2020-06; Batch #, M9210M, Exp Date, 2020-06; Batch #, M92120, Exp Date, 2020-06; Batch #, M92141, Exp Date, 2020-06; Batch #, M9214Y, Exp Date, 2020-06; Batch #, M9215L, Exp Date, 2020-06; Batch #, M9217U, Exp Date, 2020-06; Batch #, M9219T, Exp Date, 2020-06; Batch #, M9221P, Exp Date, 2020-06; Batch #, M92233, Exp Date, 2020-06; Batch #, M9226X, Exp Date, 2020-06; Batch #, M9228L, Exp Date, 2020-06; Batch #, M9231D, Exp Date, 2020-06; Batch #, M9232M, Exp Date, 2020-06; Batch #, M92356, Exp Date, 2020-06; Batch #, M9237D, Exp Date, 2020-06; Batch #, M9239T, Exp Date, 2020-06; Batch #, M9240M, Exp Date, 2020-06; Batch #, M9241E, Exp Date, 2020-06; Batch #, M9243X, Exp Date, 2020-06; Batch #, M92443, Exp Date, 2020-06; Batch #, M9246N, Exp Date, 2020-06; Batch #, M9249D, Exp Date, 2020-06; Batch #, M92517, Exp Date, 2020-06; Batch #, M9251J, Exp Date, 2020-06; Batch #, M92554, Exp Date, 2020-06; Batch #, M9255P, Exp Date, 2020-06; Batch #, M9259G, Exp Date, 2020-06; Batch #, M9259T, Exp Date, 2020-06; Batch #, M92613, Exp Date, 2020-06; Batch #, M92634, Exp Date, 2020-06; Batch #, M9264E, Exp Date, 2020-06; Batch #, M9264N, Exp Date, 2020-06; Batch #, M92673, Exp Date, 2020-06; Batch #, M9269M, Exp Date, 2020-07; Batch #, M92718, Exp Date, 2020-07; Batch #, M92738, Exp Date, 2020-07; Batch #, M9275D, Exp Date, 2020-07; Batch #, M9275X, Exp Date, 2020-07; Batch #, M92783, Exp Date, 2020-07; Batch #, M9278N, Exp Date, 2020-07; Batch #, M9280J, Exp Date, 2020-07; Batch #, M92839, Exp Date, 2020-07; Batch #, M9284P, Exp Date, 2020-07; Batch #, M92880, Exp Date, 2020-02; Batch #, M92894, Exp Date, 2020-07; Batch #, M92928, Exp Date, 2020-07; Batch #, M92935, Exp Date, 2020-07; Batch #, M9295Y, Exp Date, 2020-07; Batch #, M9295Z, Exp Date, 2020-07; Batch #, M92A3A, Exp Date, 2020-07; Batch #, M92A59, Exp Date, 2020-07; Batch #, M92A84, Exp Date, 2020-07; Batch #, M92A8U, Exp Date, 2020-07; Batch #, M92C0A, Exp Date, 2020-07; Batch #, M92C2U, Exp Date, 2020-07; Batch #, M92C51, Exp Date, 2020-07; Batch #, M92C76, Exp Date, 2020-07; Batch #, M92C8Z, Exp Date, 2020-07; Batch #, M92C9H, Exp Date, 2020-07; Batch #, M92D1U, Exp Date, 2020-07; Batch #, M92D2G, Exp Date, 2020-07; Batch #, M92D6K, Exp Date, 2020-07; Batch #, M92D6N, Exp Date, 2020-07; Batch #, M92D6P, Exp Date, 2020-07; Batch #, M92D6R, Exp Date, 2020-07; Batch #, M92E1F, Exp Date, 2020-07; Batch #, M92E36, Exp Date, 2020-07; Batch #, M92E4N, Exp Date, 2020-07; Batch #, M92E5X, Exp Date, 2020-07; Batch #, M92E6U, Exp Date, 2020-07; Batch #, M92E7R, Exp Date, 2020-07; Batch #, M92E9V, Exp Date, 2020-07; Batch #, M92F1U, Exp Date, 2020-07; Batch #, M92F1V, Exp Date, 2020-07; Batch #, M92F38, Exp Date, 2020-07; Batch #, M92F3A, Exp Date, 2020-07; Batch #, M92F5J, Exp Date, 2020-07; Batch #, M92F7C, Exp Date, 2020-07; Batch #, M92G0M, Exp Date, 2020-07; Batch #, M92G1P, Exp Date, 2020-07; Batch #, M92G41, Exp Date, 2020-07; Batch #, M92G5F, Exp Date, 2020-07; Batch #, M92G7C, Exp Date, 2020-07; Batch #, M92H07, Exp Date, 2020-07; Batch #, M92H13, Exp Date, 2020-07; Batch #, M92H24, Exp Date, 2020-07; Batch #, M92H3H, Exp Date, 2020-07; Batch #, M92H4M, Exp Date, 2020-07; Batch #, M92H7D, Exp Date, 2020-07; Batch #, M92H9Z, Exp Date, 2020-07; Batch #, M92J2Y, Exp Date, 2020-07; Batch #, M92J9Z, Exp Date, 2020-08; Batch #, M92K27, Exp Date, 2020-08; Batch #, M92K36, Exp Date, 2020-08; Batch #, M92K53, Exp Date, 2020-08; Batch #, M92K71, Exp Date, 2020-08; Batch #, M92K7F, Exp Date, 2020-08; Batch #, M92L14, Exp Date, 2020-08; Batch #, M92L1L, Exp Date, 2020-08; Batch #, M92L1V, Exp Date, 2020-08; Batch #, M92M3V, Exp Date, 2020-08; Batch #, M92M76, Exp Date, 2020-08; Batch #, M92M9G, Exp Date, 2020-08; Batch #, M92N2A, Exp Date, 2020-08; Batch #, M92N4Y, Exp Date, 2020-08 & Batch #, M92N72, Exp Date, 2020-08.  Model # HARH45: Batch #, L90K4R, Exp Date, 2019-02; Batch #, L90V8F, Exp Date, 2019-03; Batch #, L90X10, Exp Date, 2019-03; Batch #, L91358, Exp Date, 2019-04; Batch #, L91600, Exp Date, 2019-04; Batch #, L9166U, Exp Date, 2019-04; Batch #, L9168T, Exp Date, 2019-04; Batch #, L91809, Exp Date, 2019-04; Batch #, L91E83, Exp Date, 2019-05; Batch #, L91G7W, Exp Date, 2019-05; Batch #, L91J6R, Exp Date, 2019-05; Batch #, L91M0D, Exp Date, 2019-06; Batch #, L91M6C, Exp Date, 2019-06; Batch #, L91R4J, Exp Date, 2019-06; Batch #, L91U69, Exp Date, 2019-06; Batch #, L91W66, Exp Date, 2019-06; Batch #, L91Y4Y, Exp Date, 2019-07; Batch #, L91Z72, Exp Date, 2019-07; Batch #, L9207J, Exp Date, 2019-07; Batch #, L92360, Exp Date, 2019-07; Batch #, L9236W, Exp Date, 2019-07; Batch #, L9246M, Exp Date, 2019-07; Batch #, L9252P, Exp Date, 2019-07; Batch #, L9257K, Exp Date, 2019-08; Batch #, L92619, Exp Date, 2019-08; Batch #, L92690, Exp Date, 2019-08; Batch #, L9281C, Exp Date, 2019-08; Batch #, L9288P, Exp Date, 2019-08; Batch #, L9294J, Exp Date, 2019-08; Batch #, L92A2U, Exp Date, 2019-08; Batch #, L92A8A, Exp Date, 2019-08; Batch #, L92C8U, Exp Date, 2019-08; Batch #, L92D7A, Exp Date, 2019-08; Batch #, L92H1J, Exp Date, 2019-09; Batch #, L92H3T, Exp Date, 2019-09; Batch #, L92H79, Exp Date, 2019-09; Batch #, L92H7K, Exp Date, 2019-09; Batch #, L92J40, Exp Date, 2019-09; Batch #, L92K54, Exp Date, 2019-09; Batch #, L92K8Z, Exp Date, 2019-09; Batch #, L92L1C, Exp Date, 2019-09; Batch #, L92M3W, Exp Date, 2019-09; Batch #, L92P9N, Exp Date, 2019-09; Batch #, L92T19, Exp Date, 2019-10; Batch #, L92U1H, Exp Date, 2019-10; Batch #, L92V3L, Exp Date, 2019-10; Batch #, L92V8R, Exp Date, 2019-10; Batch #, L92W46, Exp Date, 2019-10; Batch #, L92X6G, Exp Date, 2019-10; Batch #, L92Y3C, Exp Date, 2019-10; Batch #, L92Y8Z, Exp Date, 2019-10; Batch #, L92Z8P, Exp Date, 2019-10; Batch #, L9303M, Exp Date, 2019-10; Batch #, L93240, Exp Date, 2019-11; Batch #, L93248, Exp Date, 2019-11; Batch #, L93426, Exp Date, 2019-11; Batch #, L9359C, Exp Date, 2019-11; Batch #, M9007E, Exp Date, 2019-12; Batch #, M9007F, Exp Date, 2019-12; Batch #, M90138, Exp Date, 2019-12; Batch #, M9024R, Exp Date, 2019-12; Batch #, M9025P, Exp Date, 2019-12; Batch #, M9030N, Exp Date, 2019-12; Batch #, M9047L, Exp Date, 2019-12; Batch #, M90545, Exp Date, 2019-12; Batch #, M9062G, Exp Date, 2019-12; Batch #, M9080T, Exp Date, 2019-12; Batch #, M90858, Exp Date, 2019-12; Batch #, M9097F, Exp Date, 2019-12; Batch #, M90C11, Exp Date, 2020-01; Batch #, M90C5Y, Exp Date, 2020-01; Batch #, M90D61, Exp Date, 2020-01; Batch #, M90E1V, Exp Date, 2020-01; Batch #, M90F7R, Exp Date, 2020-01; Batch #, M90G3W, Exp Date, 2020-01; Batch #, M90H03, Exp Date, 2020-01; Batch #, M90J4R, Exp Date, 2020-01; Batch #, M90M71, Exp Date, 2020-02; Batch #, M90M9E, Exp Date, 2020-02; Batch #, M90P0E, Exp Date, 2020-02; Batch #, M90T4D, Exp Date, 2020-02; Batch #, M90U8F, Exp Date, 2020-02; Batch #, M90W1V, Exp Date, 2020-02; Batch #, M90X96, Exp Date, 2020-02; Batch #, M90Z1G, Exp Date, 2020-03; Batch #, M90Z52, Exp Date, 2020-03; Batch #, M91053, Exp Date, 2020-03; Batch #, M9125X, Exp Date, 2020-03; Batch #, M9141X, Exp Date, 2020-03; Batch #, M9145F, Exp Date, 2020-03; Batch #, M9164C, Exp Date, 2020-03; Batch #, M9166Y, Exp Date, 2020-03; Batch #, M91984, Exp Date, 2020-04; Batch #, M91D17, Exp Date, 2020-04; Batch #, M91F19, Exp Date, 2020-04; Batch #, M91G1N, Exp Date, 2020-04; Batch #, M91H11, Exp Date, 2020-04; Batch #, M91J0M, Exp Date, 2020-04; Batch #, M91J2G, Exp Date, 2020-04; Batch #, M91L0A, Exp Date, 2020-05; Batch #, M91M1C, Exp Date, 2020-05; Batch #, M91P13, Exp Date, 2020-05; Batch #, M91R3J, Exp Date, 2020-05; Batch #, M91R4M, Exp Date, 2020-05; Batch #, M91R53, Exp Date, 2020-05; Batch #, M91U3L, Exp Date, 2020-05; Batch #, M91V21, Exp Date, 2020-05; Batch #, M91X28, Exp Date, 2020-05; Batch #, M91X4G, Exp Date, 2020-05; Batch #, M91X6W, Exp Date, 2020-06; Batch #, M91Y1Y, Exp Date, 2020-06; Batch #, M91Y3D, Exp Date, 2020-06; Batch #, M91Y7J, Exp Date, 2020-06; Batch #, M9202G, Exp Date, 2020-06; Batch #, M92126, Exp Date, 2020-06; Batch #, M92189, Exp Date, 2020-06; Batch #, M9222C, Exp Date, 2020-06; Batch #, M9224U, Exp Date, 2020-06; Batch #, M9246P, Exp Date, 2020-06; Batch #, M9255N, Exp Date, 2020-06; Batch #, M9273G, Exp Date, 2020-07; Batch #, M92884, Exp Date, 2020-07; Batch #, M9291P, Exp Date, 2020-07; Batch #, M92A24, Exp Date, 2020-07; Batch #, M92A67, Exp Date, 2020-07; Batch #, M92D6L, Exp Date, 2020-07; Batch #, M92E0X, Exp Date, 2020-07; Batch #, M92F1X, Exp Date, 2020-07; Batch #, M92F5K, Exp Date, 2020-07; Batch #, M92F8N, Exp Date, 2020-07; Batch #, M92J31, Exp Date, 2020-08; Batch #, M92J9N, Exp Date, 2020-08; Batch #, M92K6E, Exp Date, 2020-08; Batch #, M92L5C, Exp Date, 2020-08; Batch #, M92L5T, Exp Date, 2020-08; Batch #, M92L7G, Exp Date, 2020-08 & Batch #, M92N47, Exp Date, 2020-08.

Root Cause

Device Design

Action Taken

On October 5, 2015, the firm sent Urgent Medical Device Recall Removal Letters to their customers.

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