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
This recall has been terminated (originally issued April 19, 2019).
- Company
- Ethicon, Inc. Us
- Recall Initiated
- April 19, 2019
- Terminated
- February 5, 2021
- Recall Number
- Z-1841-2019
- Quantity
- 1296 eaches
- Firm Location
- Somerville, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Distribution
Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
Lot / Code Info
Lot Code: PBQ426
Root Cause
Material/Component Contamination
Action Taken
Ethicon notified primary and secondary US consignees by telephone on 4/19/19 and follow-up letter dated April 24, 2019 stating reason for recall, health risk and action to take: examine inventory, remove product for return. Complete the Business Reply Form (BRF) to Stericycle at 1-844-721-3045 or ethicon5905@stericycle.com. Questions regarding this action or to report any customer complaints, please contact your Ethicon sales representative or contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 8:00 AM to 6:00 PM ET.