Device product
ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
Z-1841-2019
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 82909
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1296 eaches
- Official record key
device-enforcement:Z-1841-2019
Official wording
Reason: Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Code information: Lot Code: PBQ426
Distribution pattern: Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
Derived failure modes
-
Unknown
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot