Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straigh
FDA device recall Z-1869-2009 · posted 2009-08-31 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular
- Reason for recall
- Undeclared allergen: Products are missing the warning label declaring that the products contain natural rubber latex.
- Action taken
- Maquet Cardiovascular issued a notification letter to consignees on May 19, 2009.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 2,226 devices
- Distribution
- Nationwide distribution.
- Date initiated
- 2009-05-19
- Date posted
- 2009-08-31
- Date terminated
- 2010-12-21
- Location
- San Jose, CA
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