Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65945; d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66150; e) STERILE STRT IRIS SCISSOR (IS163), Product Code 66155; f) STERILE LITTAUER SCISSOR (LI027), Product Code 66215; g) STERILE 5-1/2" S/S SCISSOR (SS507), Product Code 66260; h) STERILE STRT MAYO SCISSOR (ST129), Product Code 66350; i) STERILE CURV METZENBAUM SCISSOR (MBS141), Product Code 66365; j) STERILE SATIN IRIS SCISSOR (IS163S), Product Code 66450; k) STERILE SATIN CURV IRIS SCISSOR (IC164S), Product Code 66465; l) STERILE CURV MAYO SCISSOR 5 1/2" (81310), Product Code 66665; m) STERILE 4-1/2 S/B SATIN SCISSOR (I142S), Product Code 66710; n) STERILE 6 1/2" S/B SCISSOR (11109SB), Product Code 66820; o) STERILE FINE LITTAUER SCISSOR (#FLS35), Product Code 66845; p) STERILE 7 IN STRT METZ SCISSOR (SM007), Product Code 66885; q) STERILE CURVED IRIS SCISSOR (IC165), Product Code 66890; r) STERILE CURVED METZENBAUM (ST142), Product Code 66895; s) STERILE B/B SCISSOR 6 1/2", Product Code 66995; t) STERILE 6 3/4" MAYO SCISSOR, Product Code 67160; u) STERILE STRT METZENBAUM SCISSORS(MBS55), Product Code 67165; v) STERILE SATIN IRIS SCISSORS W/ LG LOOPS, Product Code 67185; w) STERILE SATIN CRVD IRIS SCISSOR (IC170S), Product Code 67450; x) STERILE 51/2" EPISIOTOMY SCISSOR (11140), Product Code 67645; y) STERILE STRABISMUS SCISSOR,CRVD(81485), Product Code 67650; z) STERILE REPROCESSED 6 1/2" S/B SCISSOR, Product Code 66820K; aa) ST METZENBAUM SCISSOR CURVED 9"(MBS90C), Product Code I68510; bb) ST UMBILICAL SCISSOR, CRVD, 4" (11148), Product Code I68575; cc) ST. CASTROVIEJO SCISSOR CURVED (503655), Product Code I68790; dd) STERILE CURV SCISSOR (SS510), Product Code TRI66600; ee) ST ANGLED BANDAGE SCISSOR REPROCESS, Product Code TRI66670K; ff) STERILE STR MAYO SCISSOR 5 1/2" (ST115), Product Code TRI67630 MEDLINE: MEDLINE manual surgical kits labeled as: a) O.R. SCISSORS, S/B, 5.5 STERILE, Product Code DYND04000; b) O R SCISSORS S/B 5.5 HG STERILE, Product Code DYND04133
This recall is currently active, issued March 29, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- February 23, 2024
- Posted
- March 29, 2024
- Recall Number
- Z-1444-2024
- Quantity
- 568,849 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Lot / Code Info
a) 65145, UDI/DI 60653160023758 (case) 00653160023756 (each), Lot Numbers: 2023071990, 2023100390; b) 65940, UDI/DI 70653160018805 (case) 00653160018806 (each), Lot Numbers: 2023112290; c) 65945, UDI/DI 60653160024823 (case) 00653160024821 (each), Lot Numbers: 2023041290, 2023042890, 2023050190, 2023051890, 2023051990, 2023052290, 2023052490, 2023052590, 2023062090, 2023071490, 2023071790, 2023090290, 2023110190; d) 66150, UDI/DI 60653160023765 (case) 00653160023763 (each), Lot Numbers: 2023041390, 2023071490, 2023091890, 2023101190; e) 66155, UDI/DI 70653160022970 (case) 00653160022971 (each), Lot Numbers: 2023030390, 2023032990, 2023033090, 2023041890, 2023071090; f) 66215, UDI/DI 60653160004863 (case) 00653160004861 (each), Lot Numbers: 2023052690, 2023102790; g) 66260, UDI/DI 60653160008366 (case) 00653160008364 (each), Lot Numbers: 2023022290; h) 66350, UDI/DI 50653160018306 (case) 00653160018301 (each), Lot Numbers: 2023062790, 2023091190; i) 66365, UDI/DI 10653160025672 (case) 00653160025675 (each), Lot Numbers: 2023041990, 2023072890; j) 66450, UDI/DI 60653160022348 (case) 00653160022346 (each), Lot Numbers: 2023022890, 2023030190; k) 66465, UDI/DI 10653160023067 (case) 00653160023060 (each), Lot Numbers: 2023063090; l) 66665, UDI/DI 60653160082717 (case) 00653160082715 (each), Lot Numbers: 2023061490, 2023071990, 2023100690; m) 66710, UDI/DI 70653160046341 (case) 00653160046342 (each), Lot Numbers: 2023111090; n) 66820, UDI/DI 60653160028289 (case) 00653160028287 (each), Lot Numbers: 2023061490, 2023101890; o) 66845, UDI/DI 60653160048058 (case) 00653160048056 (each), Lot Numbers: 2023090190; p) 66885, UDI/DI 50653160049256 (case) 00653160049251 (each), Lot Numbers: 2023030990; q) 66890, UDI/DI 60653160049246 (case) 00653160049244 (each), Lot Numbers: 2023040690, 2023041090, 2023100990; r) 66895, UDI/DI 50653160006563 (case) 00653160006568 (each), Lot Numbers: 2023102690; s) 66995, UDI/DI 60653160048393 (case) 00653160048391 (each), Lot Numbers: 2023032390, 2023110390; t) 67160, UDI/DI 50653160052195 (case) 00653160052190 (each), Lot Numbers: 2023032790; u) 67165, UDI/DI 60653160046962 (case) 00653160046960 (each), Lot Numbers: 2023030390; v) 67185, UDI/DI 60653160038745 (case) 00653160038743 (each), Lot Numbers: 2023042590, 2023112290; w) 67450, UDI/DI 30653160134989 (case) 00653160134988 (each), Lot Numbers: 2023100690; x) 67645, UDI/DI 30653160195850 (case) 00653160195859 (each), Lot Numbers: 2023021490, 2023060790, 2023112790; y) 67650, UDI/DI 30653160195867 (case) 00653160195866 (each), Lot Numbers: 2023030390; z) 66820K, UDI/DI 00653160351408 (case) 10653160351405 (each), Lot Numbers: 2023050890 (not distributed) aa) I68510, UDI/DI 00653160293074 (case) 10653160293071 (each), Lot Numbers: 2023031390, 2023091890; bb) I68575, UDI/DI 00653160306675 (case) 10653160306672 (each), Lot Numbers: 2023022290, 2023041190, 2023060790; cc) I68790, UDI/DI 00653160327656 (case) 10653160327653 (each), Lot Numbers: 2023101890, 2023111690; dd) TRI66600, UDI/DI 00653160317992 (case) 10653160317999 (each), Lot Numbers: 2023021490, 2023041190; ee) TRI66670K, UDI/DI 00653160358667 (case) 10653160358664 (each), Lot Numbers: 2023030990, 2023040690; ff) TRI67630, UDI/DI 00653160317923 (case) 10653160317920 (each), Lot Numbers: 2023100690, 2023112790; MEDLINE: a) DYND04000, UDI/DI 20193489191346 (case) 10193489191349 (each), Lot Numbers: 2023021490, 2023050390, 2023050590, 2023050790, 2023051090, 2023050690, 2023050890, 2023050990, 2023051190, 2023051290, 2023051390, 2023051690, 2023050490, 2023051890, 2023051990, 2023052090, 2023052290, 2023052390, 2023052590, 2023052690, 2023052790, 2023052990, 2023053090, 2023060190, 2023060490, 2023060790, 2023060990, 2023061090, 2023061390, 2023061490, 2023061590, 2023070690, 2023081790, 2023081890, 2023101690, 2023102490, 2023102590, 2023102790, 2023102890, 2023102690, 2023112290, 2023112390, 2023110790; b) DYND04133, UDI/DI 20193489191360 (case) 10193489191363 (each), Lot Numbers: 2023033190, 2023101890
Root Cause
Process control
Action Taken
Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers.