Centurion manual surgical kits labeled as: a) STERILE recall: Sterility Concern
Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product…
Why was Centurion manual surgical kits labeled as: a) STERILE recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 60075 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Recall date
- April 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)