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FDAJuly 19, 2022device

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

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

The hazard

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

What to do

FDA enforcement status: Ongoing

Brands named

cook

UPCs

00827002561731

Recall history

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

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