Recall Monitor
Health Products

PERMA-HAND™ Silk Suture

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: PERMA-HAND™ Silk Suture
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
PERMA-HAND™ Silk SutureRLBDPJN271H

Issue

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.

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