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FDAMarch 1, 2024device

Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6.0-38-15 5) JCD8.0-38...

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

The hazard

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

What to do

FDA enforcement status: Ongoing

Brands named

cook

UPCs

008270020099360082700201471800827002014725008270020094480082700200999800827002009806

Recall history

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

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