Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF j. ARTHROSCOPY PACK-LF k. ARTHROSCOPY BASIN PACK-LF l. ARTHROTOMY PACK-LF m. ARTHROSCOPY PACK-LF n. ARTHROSCOPY PACK o. ARTHROSCOPY PACK p. ARTHROSCOPY PACK q. ARTHROSCOPY PACK - LF r. SC ARTHROSCOPY PACK s. ARTHROSCOPY PACK-LF t. ARTHROSCOPY PACK u. ARTHROSCOPY PACK v. ARTHROSCOPY PACK w. OSC ARTHROSCOPY PK-LF x. ARTHROSCOPY PACK y. ARTHROSCOPY PACK z. ARTHROSCOPY PACK aa. ARTHROSCOPY PACK bb. ARTHROSCOPY PACK cc. KNEE ARTHROSCOPY PACK dd. KNEE ARTHROSCOPY PACK ee. SHOULDER ARTHROSCOPY PACK ff. SHOULDER ARTHROSCOPY gg. ARTHROSCOPY PACK hh. ARTHROSCOPY PACK ii. ARTHROSCOPY PACK jj. ARTHROSCOPY PACK kk. ARTHROSCOPY PACK ll. ARTHROSCOPY PACK-LF mm. ARTHROSCOPY KNEE nn. ARTHROSCOPY PACK oo. HIP ARTHROSCOPY PACK pp. ARTHROSCOPY PACK qq. MG NS KNEE ARTHROSCOPY PACK rr. KNEE ARTHROSCOPY PACK ss. ARTHROSCOPY PACK tt. ARTHROSCOPY-LF uu. ARTHROSCOPY KIT vv. SHOULDER ARTHROSCOPY ww. KNEE ARTHROSCOPY xx. ARTHROSCOPY PACK
- Recall Initiated
- November 17, 2022
- Posted
- February 6, 2023
- Recall Number
- Z-1097-2023
- Quantity
- 1,419 cases (4,349 units)
- Firm Location
- Northfield, IL
Reason for Recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Lot / Code Info
a. KNEE ARTHROSCOPY CDS-LF, Item Number: CDS940869U, Case UDI/GTIN: 40195327210046, Unit UDI/GTIN: 10195327210045, Lot Number: 22JBR468,22JBA443; b. ARTHROSCOPY CDS, Item Number: CDS985208B, Case UDI/GTIN: 40889942942061, Unit UDI/GTIN: 10889942942060, Lot Number: 22JBR379,22IBS410,22IBO331,22IBO332; c. ARTHROSCOPY LV - EDOC PACK-LF, Item Number: DYNJ0111409L, Case UDI/GTIN: 40889942824015, Unit UDI/GTIN: 10889942824014, Lot Number: 22JMH535,22IMF440; d. ARTHROSCOPY PACK-LF, Item Number: DYNJ0376528J, Case UDI/GTIN: 40889942395935, Unit UDI/GTIN: 10889942395934, Lot Number: 22JBJ567; e. ARTHROSCOPY PACK, Item Number: DYNJ04446N, Case UDI/GTIN: 40888277753649, Unit UDI/GTIN: 10888277753648, Lot Number: 22JMH875,22HMG756; f. ARTHRO PACK-LF, Item Number: DYNJ0637509B, Case UDI/GTIN: 40889942079255, Unit UDI/GTIN: 10889942079254, Lot Number: 22IMH393; g. ARTHROSCOPY PACK-LF, Item Number: DYNJ0751097M, Case UDI/GTIN: 40195327196364, Unit UDI/GTIN: 10195327196363, Lot Number: 22HMC138; h. ARTHROSCOPY PACK-LF, Item Number: DYNJ0890114F, Case UDI/GTIN: 40889942824039, Unit UDI/GTIN: 10889942824038, Lot Number: 22JMC992,22IMG334; i. ARTHROSCOPY KNEE TRAY-LF, Item Number: DYNJ09577J, Case UDI/GTIN: 40889942104803, Unit UDI/GTIN: 10889942104802, Lot Number: 22IBJ738; j. ARTHROSCOPY PACK-LF, Item Number: DYNJ15916C, Case UDI/GTIN: 40888277861610, Unit UDI/GTIN: 10888277861619, Lot Number: 22KBA679,22JBS955; k. ARTHROSCOPY BASIN PACK-LF, Item Number: DYNJ16633C, Case UDI/GTIN: 40888277858450, Unit UDI/GTIN: 10888277858459, Lot Number: 22JBV974; l. ARTHROTOMY PACK-LF, Item Number: DYNJ19751B, Case UDI/GTIN: 40884389018423, Unit UDI/GTIN: 10884389018422, Lot Number: 22IME726; m. ARTHROSCOPY PACK-LF, Item Number: DYNJ24861D, Case UDI/GTIN: 40888277545398, Unit UDI/GTIN: 10888277545397, Lot Number: 22JBJ980,22JBG368; n. ARTHROSCOPY PACK, Item Number: DYNJ26870I, Case UDI/GTIN: 40889942605669, Unit UDI/GTIN: 10889942605668, Lot Number: 22IBN707; o. ARTHROSCOPY PACK, Item Number: DYNJ30719C, Case UDI/GTIN: 40888277077745, Unit UDI/GTIN: 10888277077744, Lot Number: 22JBW329; p. ARTHROSCOPY PACK, Item Number: DYNJ31889C, Case UDI/GTIN: 40889942122777, Unit UDI/GTIN: 10889942122776, Lot Number: 22JBF800; q. ARTHROSCOPY PACK - LF, Item Number: DYNJ33193A, Case UDI/GTIN: 40884389363967, Unit UDI/GTIN: 10884389363966, Lot Number: 22IBD173; r. SC ARTHROSCOPY PACK, Item Number: DYNJ34330C, Case UDI/GTIN: 40889942577027, Unit UDI/GTIN: 10889942577026, Lot Number: 22IMD384; s. ARTHROSCOPY PACK-LF, Item Number: DYNJ34797I, Case UDI/GTIN: 40889942451693, Unit UDI/GTIN: 10889942451692, Lot Number: 22IMC421; t. ARTHROSCOPY PACK, Item Number: DYNJ35435C, Case UDI/GTIN: 40888277554697, Unit UDI/GTIN: 10888277554696, Lot Number: 22JBF703; u. ARTHROSCOPY PACK, Item Number: DYNJ35733F, Case UDI/GTIN: 40889942107866, Unit UDI/GTIN: 10889942107865, Lot Number: 22IBN489; v. ARTHROSCOPY PACK, Item Number: DYNJ36624D, Case UDI/GTIN: 40889942540304, Unit UDI/GTIN: 10889942540303, Lot Number: 22JBG374,22IBA906; w. OSC ARTHROSCOPY PK-LF, Item Number: DYNJ37381C, Case UDI/GTIN: 40889942292210, Unit UDI/GTIN: 10889942292219, Lot Number: 22JBY499,22JBB033,22HBY104; x. ARTHROSCOPY PACK, Item Number: DYNJ40334, Case UDI/GTIN: 40884389852737, Unit UDI/GTIN: 10884389852736, Lot Number: 22JBK330; y. ARTHROSCOPY PACK, Item Number: DYNJ42208B, Case UDI/GTIN: 40888277744142, Unit UDI/GTIN: 10888277744141, Lot Number: 22JBP189; z. ARTHROSCOPY PACK, Item Number: DYNJ45173D, Case UDI/GTIN: 40889942485223, Unit UDI/GTIN: 10889942485222, Lot Number: 22JBG783; aa. ARTHROSCOPY PACK, Item Number: DYNJ45340B, Case UDI/GTIN: 40889942120605, Unit UDI/GTIN: 10889942120604, Lot Number: 22IBL202; bb. ARTHROSCOPY PACK, Item Number: DYNJ47103C, Case UDI/GTIN: 40889942489177, Unit UDI/GTIN: 10889942489176, Lot Number: 22JMH577,22IME064; cc. KNEE ARTHROSCOPY PACK, Item Number: DYNJ48572, Case UDI/GTIN: 40888277913890, Unit UDI/GTIN: 10888277913899, Lot Number: 22JBH940; dd. KNEE ARTHROSCOPY PACK, Item Number: DYNJ50120D, Case UDI/GTIN: 40195327195657, Unit UDI/GTIN: 10195327195656, Lot Number: 22JBG571; ee. SHOULDER ARTHROSCOPY PACK, Item Number: DYNJ50126D, Case UDI/GTIN: 40195327212170, Unit UDI/GTIN: 10195327212179, Lot Number: 22JBG572,22IBD245; ff. SHOULDER ARTHROSCOPY, Item Number: DYNJ51381, Case UDI/GTIN: 40889942161325, Unit UDI/GTIN: 10889942161324, Lot Number: 22JBG797; gg. ARTHROSCOPY PACK, Item Number: DYNJ52778A, Case UDI/GTIN: 40889942638117, Unit UDI/GTIN: 10889942638116, Lot Number: 22HMC946; hh. ARTHROSCOPY PACK, Item Number: DYNJ52813, Case UDI/GTIN: 40889942328926, Unit UDI/GTIN: 10889942328925, Lot Number: 22JBD518; ii. ARTHROSCOPY PACK, Item Number: DYNJ56088A, Case UDI/GTIN: 40888277762900, Unit UDI/GTIN: 10888277762909, Lot Number: 22JBW279,22HBR114; jj. ARTHROSCOPY PACK, Item Number: DYNJ57151, Case UDI/GTIN: 40889942721901, Unit UDI/GTIN: 10889942721900, Lot Number: 22JBI446; kk. ARTHROSCOPY PACK, Item Number: DYNJ57741, Case UDI/GTIN: 40889942773672, Unit UDI/GTIN: 10889942773671, Lot Number: 22JBD988; ll. ARTHROSCOPY PACK-LF, Item Number: DYNJ58470, Case UDI/GTIN: 40889942856030, Unit UDI/GTIN: 10889942856039, Lot Number: 22JBT149,22IBU283; mm. ARTHROSCOPY KNEE, Item Number: DYNJ68081B, Case UDI/GTIN: 40195327199853, Unit UDI/GTIN: 10195327199852, Lot Number: 22IBN483; nn. ARTHROSCOPY PACK, Item Number: DYNJ82486, Case UDI/GTIN: 40195327197422, Unit UDI/GTIN: 10195327197421, Lot Number: 22HBT060; oo. HIP ARTHROSCOPY PACK, Item Number: DYNJ82503, Case UDI/GTIN: 40195327197378, Unit UDI/GTIN: 10195327197377, Lot Number: 22HBL505; pp. ARTHROSCOPY PACK, Item Number: DYNJ82546, Case UDI/GTIN: 40195327197927, Unit UDI/GTIN: 10195327197926, Lot Number: 22HBV066; qq. MG NS KNEE ARTHROSCOPY PACK, Item Number: DYNJ82585, Case UDI/GTIN: 40195327198764, Unit UDI/GTIN: 10195327198763, Lot Number: 22IBE887; rr. KNEE ARTHROSCOPY PACK, Item Number: DYNJ82630, Case UDI/GTIN: 40195327199525, Unit UDI/GTIN: 10195327199524, Lot Number: 22JBE442; ss. ARTHROSCOPY PACK, Item Number: DYNJ82707, Case UDI/GTIN: 40195327202317, Unit UDI/GTIN: 10195327202316, Lot Number: 22JMH335,22JMF855; tt. ARTHROSCOPY-LF, Item Number: DYNJ903247B, Case UDI/GTIN: 40889942754664, Unit UDI/GTIN: 10889942754663, Lot Number: 22JBQ059; uu. ARTHROSCOPY KIT, Item Number: DYNJ904304G, Case UDI/GTIN: 40195327209316, Unit UDI/GTIN: 10195327209315, Lot Number: 22JBR652,22IBT829; vv. SHOULDER ARTHROSCOPY, Item Number: DYNJ908907, Case UDI/GTIN: 40195327215577, Unit UDI/GTIN: 10195327215576, Lot Number: 22JBJ375; ww. KNEE ARTHROSCOPY, Item Number: DYNJ908920, Case UDI/GTIN: 40195327215874, Unit UDI/GTIN: 10195327215873, Lot Number: 22JBA830; xx. ARTHROSCOPY PACK, Item Number: DYNJHS0101I, Case UDI/GTIN: 40888277046413, Unit UDI/GTIN: 10888277046412, Lot Number: 22IBK139
Root Cause
Device Design
Action Taken
Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.