Health product recall

PERMA-HAND™ Silk Suture

Brand(s)
Last updated

Summary

Product
PERMA-HAND™ Silk Suture
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

PERMA-HAND™ Silk Suture

RLBDPJ

N271H

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Ethicon LLC

Highway 183 Km 8.3, San Lorenzo, Puerto Rico, United States, 00754

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82681

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