Product Wiki · Recalls · Health Canada — Medical Devices

MERSILENE FIBER SUTURES AND WOVEN TAPE (2016-08-05) — recall 55986

Health Canada — Medical Devices · Canada · 2016-08-19 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
55986
Date of alert
2016-08-19
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Ethicon has initiated a worldwide medical device correction (notification) for unexpired lots of select Ethicon MERSILENE tape (also referred to as MERSILENE polyester fiber strip or MERSILENE fiber ligature) products as it was discovered that a group of MERSILENE tape product codes are being supplied with an incorrect instructions for use (IFU) insert. The product codes subject to this correction are being supplied with a MERSILENE Suture IFU. Corrective actions are currently being implemented to include the correct MERSILENE tape IFU with future shipments of MERSILENE tape products. This notification serves as an immediate correction to provide customers with the correct MERSILENE tape IFU.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/mersilene-fiber-sutures-and-wo

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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