Pump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction pump designed for use with the Richard Wol
FDA device recall Z-0537-04 · posted 2004-02-11 · Terminated
Recall details
- Recalling firm
- Richard Wolf Medical Instruments Corp.
- Reason for recall
- If the drain tube is assembled incorrectly, the suction pump will not operate as intended.
- Action taken
- The accounts were telephoned on 2/2/04 and informed of the potential to re-assemble the suction pump drain tubing incorrectly after sterilization. The accounts were sent re-designed replacement tubing sets and were requested to return the old tubing sets to Richard Wolf.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOL
- Quantity affected
- 2 tube sets
- Distribution
- Texas and Nebraska
- Date initiated
- 2004-02-02
- Date posted
- 2004-02-11
- Date terminated
- 2004-03-24
- Location
- Vernon Hills, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX (K011911) | Richard Wolf Medical Instruments Corp. | 2001-09-17 |