Class 2 Device Recall Centurion

• Date Initiated by Firm: February 23, 2024
• Date Posted: March 29, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1437-2024
• Recall Event ID: 94136
• Product Classification: Forceps, general & plastic surgery - Product Code GEN
• Product: 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
• Code Information: 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
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 886-359-1704
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 274410 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Panama, Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.