FDAJuly 1, 2024device

Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061901A BXB061902A BXB0629...

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

The hazard

Due to packaging defects, sterility assurance and heparin activity may be compromised.

What to do

FDA enforcement status: Ongoing

Brands named

w l gore associates

Recall history

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

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