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FDASeptember 4, 2018device

Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

What to do

FDA enforcement status: Terminated

Brands named

coopersurgical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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