—#92410

Product

Hemashield Gold Woven and Knitted Double Vascular Grafts.

FDA product code: MAL — Graft, Vascular, Synthetic/Biologic Composite
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K954848
Affected lot / code info: xx

Why it was recalled

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.

Root cause (FDA determination)

Package design/selection

Action the firm took

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.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2010-05-24
Posted by FDA: 2010-07-22
Terminated: 2011-07-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92410. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.