Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.
FDA device recall Z-1394-2011 · posted 2011-02-22 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Reason for recall
- A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function.
- Action taken
- Maquet hand delivered a letter to the consignee on 10/4/2010.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 4 units
- Distribution
- One hospital in New York City
- Date initiated
- 2010-09-28
- Date posted
- 2011-02-22
- Date terminated
- 2011-08-11
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM (K943803) | Janus Biomedical, Inc. | 1996-01-30 |