Health product recall

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

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

Anchor Tissue Retrieval System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

TRS-ROBO-12
TRS-ROBO-8
TRS-VATS-15
TRS100SB2
TRS175SB2
TRS190SB2

Companies
Manufacturer
Conmed Corporation
525 French Road
Utica
13502-5994
New York
UNITED STATES