Anchor Tissue Retrieval System (2019-03-20)

Starting date:

March 20, 2019

Posting date:

April 29, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69776

Last updated: 2019-04-30

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  Reason
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  Affected products

Affected Products

Anchor Tissue Retrieval System

Reason

CONMED confirmed that, during manufacture, pouches were sealed incorrectly, creating voids, or partial seals in the top seal (seal opposite chevron end - final manufacturing seal).  Some of these seal discrepancies formed an open channel from the outside environment to the pouch interior, which could potentially compromise product sterility. CONMED discovered the voids and partial seals during a separate, unrelated stock audit.

Affected products