FDA Device

Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide.

Hazard

Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.

What You Should Do

Remedy

The firm sent out recall notification on 5/4/2006. The US consignees were sent a letter via return receipt.

Products

Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lacti
Brand
Ethicon, Inc. US
UPC
Product Codes/Product Lot Numbers-Expiration Dates: J774D/SB2371-01/2008; JB725/SB2416-01/2008; J864D/SB2426-01/2008.

Units Affected

1157 dozens