Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch.
FDA Recall Z-2064-2010 · Posted 2010-07-22
Recalling FirmMaquet Cardiovascular, LLC
Recall StatusTerminated
Product CodeDSZ
Date Initiated2010-05-24
Date Terminated2011-07-14
Product Quantityxx
Reason for Recall
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.
Firm Action
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.
Root Cause
Package design/selection
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.