Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEED

Summary

The FDA issued a Class II for Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Prod 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 Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e) STERILE TISSUE FORCEP W/TEETH (TF6015), Product Code 66205; f) STERILE F/P WEBSTER NEEDLEHOLDER FN8064, Product Code 66220; g) STERILE IRIS FORCEP W/TEETH (IF250), Product Code 66275; h) STERILE TUBE CLAMP (TOC500), Product Code 66280; i) STERILE F/P SATIN NEEDLEHOLDER (FN9050S), Product Code 66355; j) STERILE 9 1/2 SPONGE FORCEP (237), Product Code 66360; k) STERILE SATIN NEEDLEHOLDER (FN6060S), Product Code 66375; l) STERILE CURV CRILE FORCEP (CF81810), Product Code 66395; m) STERILE LUCAE FORCEP (BF212), Product Code 66415; n) STERILE 6" SF MAYO NEEDLEHOLDER P/S, Product Code 66430; o) STERILE SATIN FORCEP W/TEETH (AF058S), Product Code 66440; p) STERILE 6" FACIAL NEEDLEHOLDER (FN7070S), Product Code 66470; q) STERILE BAYONET FORCEP (25695), Product Code 66490; r) STERILE WEBSTER NEEDLEHOLDER (WN8080S), Product Code 66500; s) STERILE O-H NEEDLEHOLDER (OHN7098S), Product Code 66510; t) STERILE FEILCHENFELD FORCEP (FS388), Product Code 66515; u) STERILE JEWELERS FORCEP (EA742), Product Code 66560; v) STERILE SATIN IRIS FORCEP W/TEETH IF250S, Product Code 66570; w) STERILE CURV PEAN FORCEP (81890), Product Code 66595; x) STERILE CURV 9-1/2 SPONGE FORCEP (FS950), Product Code 66605; y) STERILE SF MAYO HEGAR NDLHLDR (ST263), Product Code 66655; z) STERILE 6" DRESSING FORCEP (DF6006), Product Code 66755; aa) STERILE MAGILL FORCEP (MAGF9), Product Code 66790; bb) STERILE 7 1/4" TUBE OCCLUDING FORCEP, Product Code 66830; cc) STERILE BAUMGARTNER NEEDLEHOLDER, Product Code 66860; dd) STERILE SATIN IRIS FORCEP CVD. (IF255S), Product Code 66865; ee) STERILE ADSON FORCEP W/TYING PLATFORM, Product Code 66970; ff) ST. WEBSTER NEEDLEHOLDER/LG FINGER LOOPS, Product Code 66975; gg) STERILE CVD IRIS FORCEP (ITF4), Product Code 67005; hh) STERILE FULL CURVED IRIS FORCEP (IF145), Product Code 67015; ii) STERILE UMBILICAL LIL'TIPS FORCEP IF145U, Product Code 67060; jj) STERILE SATIN NEEDLEHOLDER (FN6060SL), Product Code 67115; kk) STERILE SCHNIDT TONSIL FORCEP, Product Code 67170; ll) STERILE BISHOP HARMON FORCEP, Product Code 67175; mm) STERILE MAYO HEGAR NEEDLEHOLDER 8"(16290, Product Code 67260; nn) STERILE UTERINE FORCEP 10" (82810), Product Code 67310; oo) STERILE 8" STR PEAN FORCEP (PF12202), Product Code 67485; pp) STERILE MICRO ADSON FORCEP (AF50MS), Product Code 67505; qq) STERILE ADSON FORCEP MICRO TIP (498MS), Product Code 67560; rr) STERILE PLASTIC FORCEP (BF44), Product Code 67590; ss) STERILE MIXTER FORCEP 5 1/2 (12225), Product Code 67700; tt) STERILE TISSUE FORCEP 8"(TF8000), Product Code 67720; uu) STERILE UMBILICAL FORCEP 1/4 CURVE(IF225, Product Code 67725; vv) STERILE DEBAKEY ATRAUMA FORCEP 8"(22546), Product Code 67740; ww) ST PAS GRADE NEEDLEHOLDER 8"(MHN8PAS), Product Code 67865; xx) ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Product Code 67870; yy) ST OR GRADE WEBSTER N/HOLDER 5"(OR2200), Product Code 67875; zz) ST.MICRO FORCEP 1/4 CRV SER TIP(MC250), Product Code 67885; aaa) STL IRIS FCP 3 1/2" X-FN ANG TP (IFC35FS, Product Code 67910; bbb) STL IRIS FRCP 3 1/2"X-FN STR TP (IFS35FS, Product Code 67915; ccc) STL ADSON FORCEP SMOOTH TIP (598P), Product Code 67925; ddd) ST.HARTMAN EAR DRESSING FORCEP (AF25714), Product Code 67940; eee) STERILE MAYO HEGAR NEEDLEHOLDER, Product Code 67945; fff) STERILE DRESSING FORCEP SERR (DF6003K), Product Code 66200K; ggg) SPONGE FORCEP STRA 9.5" REPRO STERILE, Product Code 66360K; hhh) STERILE 6" SF MAYO NDL HOLDER REPROCESS, Product Code 66430K; iii) STERILE UTERINE FORCEP 10" REPROCESS, Product Code 67310K; jjj) ST CRILE FORCEP,STR 5 1/2" SERR (SC8042), Product Code I67455; kkk) ST. HALSEY NHLDER 5",PAS QLTY TCI (P/S), Product Code I67975; lll) STR. ALLIGATOR M

Lot/Code Info: Centurion: a) 66165, UDI/DI 60653160018334 (case) 00653160018332 (each), Lot Numbers: 2023111790; b) 66185, UDI/DI 60653160004887 (case) 00653160004885 (each), Lot Numbers: 2023041090, 2023072590, 2023120190; c) 66195, UDI/DI 60653160006638 (case) 00653160006636 (each), Lot Numbers: 2023042090, 2023053090, 2023090890, 2023111790; d) 66200, UDI/DI 60653160022607 (case) 00653160022605 (each), Lot Numbers: 2023020890; e) 66205, UDI/DI 60653160031944 (case) 00653160031942 (each), Lot Numbers: 2023030390; f) 66220, UDI/DI 60653160024809 (case) 00653160024807 (each), Lot Numbers: 2023111490; g) 66275, UDI/DI 60653160038882 (case) 00653160038880 (each), Lot Numbers: 2023060690; h) 66280, UDI/DI 60653160004870 (case) 00653160004878 (each), Lot Numbers: 2023113090; i) 66355, UDI/DI 60653160023277 (case) 00653160023275 (each), Lot Numbers: 2023042790; j) 66360, UDI/DI 50653160022365 (case) 00653160022360 (each), Lot Numbers: 2023032090; k) 66375, UDI/DI 60653160004856 (case) 00653160004854 (each), Lot Numbers: 2023032790, 2023112990, 2023113090; l) 66395, UDI/DI 60653160044036 (case) 00653160044034 (each), Lot Numbers: 2023071890; m) 66415, UDI/DI 60653160018815 (case) 00653160018813 (each), Lot Numbers: 2023041390, 2023101390; n) 66430, UDI/DI 20653160041211 (case) 00653160041217 (each), Lot Numbers: 2023032390; o) 66440, UDI/DI 70653160022352 (case) 00653160022353 (each), Lot Numbers: 2023100990, 2023102790; p) 66470, UDI/DI 10653160039389 (case) 00653160039382 (each), Lot Numbers: 2023070390; q) 66490, UDI/DI 10653160009030 (case) 00653160009033 (each), Lot Numbers: 2023021690; r) 66500, UDI/DI 60653160043848 (case) 00653160043846 (each), Lot Numbers: 2023031090; s) 66510, UDI/DI 10653160050520 (case) 00653160050523 (each), Lot Numbers: 2023071290; t) 66515, UDI/DI 60653160040953 (case) 00653160040951 (each), Lot Numbers: 2023041090, 2023071290, 2023111590; u) 66560, UDI/DI 60653160018310 (case) 00653160018318 (each), Lot Numbers: 2023032090, 2023042490, 2023100390; v) 66570, UDI/DI 60653160038295 (case) 00653160038293 (each), Lot Numbers: 2023041890, 2023060790, 2023071990, 2023101390; w) 66595, UDI/DI 60653160038127 (case) 00653160038125 (each), Lot Numbers: 2023110890; x) 66605, UDI/DI 50653160006570 (case) 00653160006575 (each), Lot Numbers: 2023021390, 2023021690; y) 66655, UDI/DI 50653160011123 (case) 00653160011128 (each), Lot Numbers: 2023101790; z) 66755, UDI/DI 60653160031401 (case) 00653160031409 (each), Lot Numbers: 2023102690, 2023111390; aa) 66790, UDI/DI 50653160007676 (case) 00653160007671 (each), Lot Numbers: 2023021090, 2023110290; bb) 66830, UDI/DI 50653160042042 (case) 00653160042047 (each), Lot Numbers: 2023111490; cc) 66860, UDI/DI 10653160051268 (case) 00653160051261 (each), Lot Numbers: 2023021490, 2023032990; dd) 66865, UDI/DI 70653160040844 (case) 00653160040845 (each), Lot Numbers: 2023051990; ee) 66970, UDI/DI 60653160018792 (case) 00653160018790 (each), Lot Numbers: 2023033090, 2023072090, 2023100590; ff) 66975, UDI/DI 60653160026032 (case) 00653160026030 (each), Lot Numbers: 2023101290; gg) 67005, UDI/DI 10653160107415 (case) 00653160107418 (each), Lot Numbers: 2023100690; hh) 67015, UDI/DI 60653160007147 (case) 00653160007145 (each), Lot Numbers: 2023052290, 2023112190; ii) 67060, UDI/DI 10653160239338 (case) 00653160061697 (each), Lot Numbers: 2023041490, 2023041790; jj) 67115, UDI/DI 60653160006683 (case) 00653160006681 (each), Lot Numbers: 2023042490; kk) 67170, UDI/DI 10653160021360 (case) 00653160021363 (each), Lot Numbers: 2023072690; ll) 67175, UDI/DI 40653160101575 (case) 00653160101577 (each), Lot Numbers: 2023050890; mm) 67260, UDI/DI 50653160062330 (case) 00653160062335 (each), Lot Numbers: 2023032790; nn) 67310, UDI/DI 10653160103264 (case) 00653160103267 (each), Lot Numbers: 2023030390; oo) 67485, UDI/DI 10653160140924 (case) 00653160140927 (each), Lot Numbers: 2023042590, 2023101990; pp) 67505, UDI/DI 10653160146568 (case) 00653160146561 (each), Lot Numbers: 2023072090; qq) 67560, UDI/DI 10653160167877 (case) 00653160167870 (each), Lot Numbers: 2023100390; rr) 67590, UDI/DI 30653160183017 (case) 00653160183016 (each), Lot Numbers: 2023050890; ss) 67700, UDI/DI 30653160195898 (case) 00653160195897 (each), Lot Numbers: 2023061290, 2023071090; tt) 67720, UDI/DI 10653160196068 (case) 00653160196061 (each), Lot Numbers: 2023042590; uu) 67725, UDI/DI 10653160195931 (case) 00653160195934 (each), Lot Numbers: 2023032790; vv) 67740, UDI/DI 10653160196099 (case) 00653160196092 (each), Lot Numbers: 2023102790; ww) 67865, UDI/DI 10653160196839 (case) 00653160196832 (each), Lot Numbers: 2023042490; xx) 67870, UDI/DI 30653160196895 (case) 00653160196894 (each), Lot Numbers: 2023032790; yy) 67875, UDI/DI 30653160196901 (case) 00653160196900 (each), Lot Numbers: 2023042790; zz) 67885, UDI/DI 30653160197861 (case) 00653160197860 (each), Lot Numbers: 2023022290; aaa) 67910, UDI/DI 10653160202059 (case) 00653160202052 (each), Lot Numbers: 2023051990, 2023060690, 2023062090; bbb) 67915, UDI/DI 30653160202060 (case) 00653160202069 (each), Lot Numbers: 2023050590; ccc) 67925, UDI/DI 30653160206914 (case) 00653160206913 (each), Lot Numbers: 2023112790; ddd) 67940, UDI/DI 10653160210177 (case) 00653160210170 (each), Lot Numbers: 2023072790; eee) 67945, UDI/DI 10653160211150 (case) 00653160211153 (each), Lot Numbers: 2023072690; fff) 66200K, UDI/DI 10653160164166 (case) 00653160164169 (each), Lot Numbers: 2023042690; ggg) 66360K, UDI/DI 00653160352801 (case) 10653160352808 (each), Lot Numbers: 2023050490, 2023050890; hhh) 66430K, UDI/DI 00653160358605 (case) 10653160358602 (each), Lot Numbers: 2023030990, 2023062890; iii) 67310K, UDI/DI 00653160358612 (case) 10653160358619 (each), Lot Numbers: 2023030990; jjj) I67455, UDI/DI 00653160257083 (case) 10653160257080 (each), Lot Numbers: 2023061290; kkk) I67975, UDI/DI 30653160223614 (case) 00653160223613 (each), Lot Numbers: 2023042490; lll) I68030, UDI/DI 10653160228288 (case) 00653160228281 (each), Lot Numbers: 2023032090; mmm) I68035, UDI/DI 10653160228417 (case) 00653160228410 (each), Lot Numbers: 2023041090; nnn) I68255, UDI/DI 00653160268423 (case) 10653160268420 (each), Lot Numbers: 2023061490, 2023081490, 2023101390; ooo) I68320, UDI/DI 00653160278842 (case) 10653160278849 (each), Lot Numbers: 2023030990; ppp) I68420, UDI/DI 00653160287707 (case) 10653160287704 (each), Lot Numbers: 2023021090, 2023091890, 2023101990; qqq) I68435, UDI/DI 00653160289206 (case) 10653160289203 (each), Lot Numbers: 2023041190; rrr) I68440, UDI/DI 00653160289213 (case) 10653160289210 (each), Lot Numbers: 2023041190; sss) I86530, UDI/DI 00653160254686 (case) 10653160254683 (each), Lot Numbers: 2023062890; ttt) P-66200, UDI/DI 60653160022607 (case) 00653160022605 (each), Lot Numbers: 2023120590 (not distributed); uuu) TRI66525, UDI/DI 00653160317589 (case) 10653160317586 (each), Lot Numbers: 2023042490, 2023062690, 2023091190, 2023102790; vvv) TRI66575, UDI/DI 00653160317688 (case) 10653160317685 (each), Lot Numbers: 2023102790; www) TRI66725, UDI/DI 00653160317961 (case) 10653160317968 (each), Lot Numbers: 2023112890; xxx) TRI66800, UDI/DI 00653160317930 (case) 10653160317937 (each), Lot Numbers: 2023040490; yyy) TRI66875, UDI/DI 00653160317893 (case) 10653160317890 (each), Lot Numbers: 2023051290; zzz) TRI66875K, UDI/DI 00653160358599 (case) 10653160358596 (each), Lot Numbers: 2023030990; aaaa) TRI66950, UDI/DI 00653160317916 (case) 10653160317913 (each), Lot Numbers: 2023060790; MEDLINE: a) DYND04009, UDI/DI 20193489191353 (case) 10193489191356 (each), Lot Numbers: 2023102490; b) DYND04010, UDI/DI 40884389096469 (case) 10884389096468 (each), Lot Numbers: 2023033190, 2023040390, 2023060290, 2023062190, 2023072090, 2023091990, 2023092990, 2023111690; c) DYNJ04048, UDI/DI 20193489195245 (case) 10193489195248 (each), Lot Numbers: 2023031090, 2023032890, 2023041890, 2023050390, 2023060890, 2023071190, 2023072590, 2023081590, 2023101990, 2023102890, 2023110890, 2023111590, 2023112290, 2023112890; d) DYNJ04052, UDI/DI 20193489195252 (case) 10193489195255 (each), Lot Numbers: 2023021590, 2023111390

Quantity Affected: 274410 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