ClearanceBrief
Recall Z-1841-2019 ยท GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Ethicon, Inc.

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

DateApr 19, 2019
StatusTerminated
ReasonPossibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Root causeMaterial/Component Contamination
ActionEthicon 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
Quantity1296 eaches
DistributionWorldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK
ETHICON, Inc., Jan 9, 1995