Z-1842-2019 Class II Terminated
FDA device recall Z-1842-2019 was initiated by Ethicon, Inc. on April 19, 2019 and is designated Class II. Reason for recall: Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot The recall status is terminated (terminated February 5, 2021). Affected quantity: 36 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2019
- Initiation Date
- April 19, 2019
- Termination Date
- February 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 eaches
Product Description
ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W 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
Reason for Recall
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Distribution Pattern
Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
Code Information
Lot Code:PBQ797