Jostra HL-20 Heart Lung Machine - guiding pins
FDA device recall Z-0159-2007 · posted 2006-11-07 · Terminated
Recall details
- Recalling firm
- MAQUET Inc.
- Reason for recall
- The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other particles accumulate in the tube guide rolls, they cannot roll smoothly and finally they can get stuck.
- Action taken
- An 'Important Safety Notice - Please Read Immediately' letter was sent to all US customers on 10/3/06 by FedEx Return Receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 227 HL-20 base units with 545 single pumps
- Distribution
- Worldwide
- Date initiated
- 2006-10-03
- Date posted
- 2006-11-07
- Date terminated
- 2007-12-19
- Location
- Bridgewater, 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 |