Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KEL

Summary

The FDA issued a Class II for Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (T by MEDLINE INDUSTRIES, LP - Northfield. Reason: 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 u.

Details

Product Description

Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837), Product Code 66810; d) STERILE PROBE (PR5), Product Code 66900; e) STERILE NAIL NIPPER, Product Code 67110; f) STERILE FREER SEPTUM ELEVATOR (FE75B), Product Code 67285; g) STERILE 5 1/2" NAIL NIPPER (32195), Product Code 67365; h) STERILE 4 1/4" CUTICLE NIPPER (32908), Product Code 67420; i) STERILE ENGLISH ANVIL NAIL SPLITTER-5", Product Code 67595; j) STERILE UNIVERSAL RING CUTTER(FS02470), Product Code 67780; k) STERILE FINGER NAIL CLIPPER, Product Code 589784ST; l) BILLEAU EAR LOOP 4MM 6" LARGE, Product Code BEL46ST; m) PROBE WITH EYE, Product Code DYND04011; n) STERILE 9" MAYO SCISSOR (ST150), Product Code I67350; o) STRL ROCHESTER OCHSNER SATIN 7 1/4", Product Code I67695; p) CMP* NAIL NIPPER ANGLED 4.5, Product Code I67980; q) STERILE BILLEAU EAR LOOP 3MM, Product Code I67995; r) ST. ALLIGATOR FORCEP, POINTED, MICRO P/S, Product Code I68020; s) MOSQUITO HEMOSTAT FINE TIP, Product Code I68190; t) STERILE VAS DEFERENS CLAMP (VDC100S), Product Code I68200; u) LILLIE EAR HOOK, 7" STERILE (P/S), Product Code I68305; v) ST FOX DERMAL CURE, 4MM, 5 1/2 (32922), Product Code I68360; w) STERILE SKIN HOOK - SHARP (SH25754), Product Code I68415; x) ST. EYE LID SPECULUM WIRE ADULT (ES500P), Product Code I68460; y) STERILE NAIL RASP DOUBLE ENDED (NR100), Product Code I68500; z) ST. SCLERAL DEPRESSOR 5.5" (SD500), Product Code I68515; aa) STERILE NAIL SPLITTING FORCEP 4" (NS400), Product Code I68600; bb) STERILE 12" PROBE W/ EYE, Product Code I68840; cc) COMEDONE EXTRACTOR, STERILE (P/S), Product Code I86540; dd) STERILE SPATULA & PACKER, Product Code I86695; ee) STERILE - PHLBCTMY HOOK CRCHT STYL 6, Product Code I86875; ff) STERILE FREER SEPTUM ELEVATOR (FE75B), Product Code P-67285 MEDLINE PROBE WITH EYE, Product Code DYND04011

Lot/Code Info: a) 66225, UDI/DI 60653160018327 (case) 00653160018325 (each), Lot Numbers: 2023070390; b) 66565, UDI/DI 20653160059865 (case) 00653160059861 (each), Lot Numbers: 2023022090; c) 66810, UDI/DI 60653160038547 (case) 00653160038545 (each), Lot Numbers: 2023042490; d) 66900, UDI/DI 60653160038868 (case) 00653160038866 (each), Lot Numbers: 2023030890, 2023100390, 2023111090; e) 67110, UDI/DI 50653160049751 (case) 00653160049756 (each), Lot Numbers: 2023042490, 2023051590, 2023110290; f) 67285, UDI/DI 50653160089139 (case) 00653160089134 (each), Lot Numbers: 2023081490, 2023101190; g) 67365, UDI/DI 10653160115120 (case) 00653160115123 (each), Lot Numbers: 2023040390, 2023090790, 2023101790, 2023110890; h) 67420, UDI/DI 10653160123491 (case) 00653160123494 (each), Lot Numbers: 2023100590; i) 67595, UDI/DI 10653160184553 (case) 00653160184556 (each), Lot Numbers: 2023032890, 2023101390; j) 67780, UDI/DI 10653160196662 (case) 00653160196665 (each), Lot Numbers: 2023071290; k) 589784ST, UDI/DI 40653160130681 (case) 00653160130683 (each), Lot Numbers: 2023020990, 2023030790, 2023042890; l) BEL46ST, UDI/DI 10653160227168 (case) 00653160227161 (each), Lot Numbers: 2023101890; m) DYND04011, UDI/DI 40884389097800 (case) 10884389097809 (each), Lot Numbers: 2023102090; n) I67350, UDI/DI 00653160286847 (case) 10653160286844 (each), Lot Numbers: 2023031390, 2023111790; o) I67695, UDI/DI 00653160263060 (case) 10653160263067 (each), Lot Numbers: 2023110290 (not distributed); p) I67980, UDI/DI 10653160224815 (case) 00653160224818 (each), Lot Numbers: 2023031690; q) I67995, UDI/DI 10653160227656 (case) 00653160227659 (each), Lot Numbers: 2023042690, 2023101790, 2023111090; r) I68020, UDI/DI 10653160228349 (case) 00653160228342 (each), Lot Numbers: 2023092990, 2023111590; s) I68190, UDI/DI 00653160263299 (case) 10653160263296 (each), Lot Numbers: 2023041390, 2023090790; t) I68200, UDI/DI 00653160263077 (case) 10653160263074 (each), Lot Numbers: 2023101890; u) I68305, UDI/DI 00653160277647 (case) 10653160277644 (each), Lot Numbers: 2023072090; v) I68360, UDI/DI 00653160280852 (case) 10653160280859 (each), Lot Numbers: 2023021490; w) I68415, UDI/DI 00653160286946 (case) 10653160286943 (each), Lot Numbers: 2023111790; x) I68460, UDI/DI 00653160289886 (case) 10653160289883 (each), Lot Numbers: 2023030990, 2023060690, 2023100390; y) I68500, UDI/DI 00653160293555 (case) 10653160293552 (each), Lot Numbers: 2023061490, 2023111390; z) I68515, UDI/DI 00653160293548 (case) 10653160293545 (each), Lot Numbers: 2023061290; aa) I68600, UDI/DI 00653160308334 (case) 10653160308331 (each), Lot Numbers: 2023042790; bb) I68840, UDI/DI 00653160331578 (case) 10653160331575 (each), Lot Numbers: 2023021690, 2023050890, 2023091890; cc) I86540, UDI/DI 00653160270907 (case) 10653160270904 (each), Lot Numbers: 2023041390; dd) I86695, UDI/DI 00653160291834 (case) 10653160291831 (each), Lot Numbers: 2023042090; ee) I86875, UDI/DI 00653160359190 (case) 10653160359197 (each), Lot Numbers: 2023032790; ff) P-67285, UDI/DI 50653160089139 (case) 00653160089134 (each), Lot Numbers: 2023120590 MEDLINE: UDI/DI 40884389097800 (case), 10884389097809 (each), Lot Numbers: 2023102090

Quantity Affected: 60075 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-02-23

Company