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Terminated

Hemashield Double Velour Cardiovascular Fabrics.

FDA Recall Z-2062-2010 · Posted 2010-07-22

Recalling FirmMaquet Cardiovascular, LLC
Recall StatusTerminated
Product CodeDXZ
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.

K955349HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRICMeadox Medicals, Div. Boston Scientific Corp. · 1996-02-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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