CanadaPERMA-HAND™ Silk Suture (Ethicon LLC), model/catalogue N271H, lot RLBDPJ, is affected. It was recalled because it was incorrectly manufactured with an alcohol-based tubing fluid (isopropyl alcohol, diethylaminoethanol, and sodium benzoate), a tubing fluid not approved for use; up to 80% of the impacted lot may have had the alcohol-based tubing fluid. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Ethicon LLC, Highway 183 Km 8.3, San Lorenzo, Puerto Rico, United States, 00754.
How to identify it
Affected products: PERMA-HAND™ Silk Suture; Lot or serial number: RLBDPJ; Model or catalogue number: N271H
The hazard
Ethicon determined that PERMA-HAND™ Silk Suture subject to this recall (removal) was incorrectly manufactured with an alcohol-based tubing fluid in the primary packaging. This tubing fluid is an isopropyl alcohol (IPA), diethylaminoethanol (DEAE), and sodium benzoate solution previously used in the manufacture of a different suture product. Up to 80% of the impacted lot may have had the alcohol-based tubing fluid. Tubing fluid is not a material approved for use in the manufacture of PERMA-HAND™ Silk Suture.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)