Hemashield Double Velour Cardiovascular Fabrics.
FDA device recall Z-2062-2010 · posted 2010-07-22 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DXZ
- Quantity affected
- xx
- Distribution
- Nationwide Distribution.
- Date initiated
- 2010-05-24
- Date posted
- 2010-07-22
- Date terminated
- 2011-07-14
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC (K955349) | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-14 |