FDA Device

Hemashield Gold Woven Double Velour Vascular Branch Graft

Hazard

Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.

What You Should Do

Remedy

Letters were sent by Federal Express commencing July 12, 2010. Distribution has to be obtained from Boston Scientific. Questions are directed to the local Sales/Service Representative, or to the firm's Customer Service at 1-888-880-2874.

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Products

Hemashield Gold Woven Double Velour Vascular Branch Graft
Brand
Maquet Cardiovascular, LLC
UPC
xxx

Units Affected

xx

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