Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank
FDA device recall Z-0158-2007 · posted 2006-11-07 · Terminated
Recall details
- Recalling firm
- MAQUET Inc.
- Reason for recall
- The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill.
- Action taken
- The firm sent a safety alert letter on 9/13/06 to all US customers by Federal Express Return Receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 132 or less in US. Firm officials stated that 66 base units in US 8/1/05 to 8/14/06 - each units comes with 2 hand cranks.
- Distribution
- worldwide
- Date initiated
- 2006-09-01
- Date posted
- 2006-11-07
- Date terminated
- 2007-12-19
- Location
- Bridgewater, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM (K943803) | Janus Biomedical, Inc. | 1996-01-30 |