Recall Z-2062-2010
Maquet Cardiovascular, LLC · initiated May 24, 2010
Product
Hemashield Double Velour Cardiovascular Fabrics.
Codes / lots: xxx
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.
FDA-determined cause: Package design/selection
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.
Details
- Recall number
- Z-2062-2010
- Initiated
- May 24, 2010
- Posted by FDA
- July 22, 2010
- Terminated
- July 14, 2011
- Product code
- DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Quantity
- xx
- Distribution
- Nationwide Distribution.
- Recalling firm
- Maquet Cardiovascular, LLC, Wayne, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2061-2010 | Hemashield Gold Woven Double Velour Vascular Branch GraftVarious Hemashield products may develop glycerol droplets on the inner blister of the package if not stored… | 05/24/2010Terminated |
| Z-2063-2010 | Hemashield Platinum Woven and Knitted Double Velour Vascular Grafts.Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored… | 05/24/2010Terminated |
| Z-2064-2010 | Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch.Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored… | 05/24/2010Terminated |
| Z-2065-2010 | Hemashield Platinum Woven Double Velour TAAA Vascular Grafts.Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored… | 05/24/2010Terminated |
| Z-2066-2010 | Hemashield Gold Woven and Knitted Double Vascular Grafts.Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored… | 05/24/2010Terminated |