Recall Z-0537-04 ยท JOL Catheter And Tip, Suction
Richard Wolf Medical Instruments Corp.
Pump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction pump designed for use with the Richard Wolf Ultrasound Lithotriptor used to disintegrate kidney stones, urinary bladder stones and ureter stones; Richard Wolf GmbH, D-75438 Knittlingen Germany
| Date | Feb 11, 2004 (initiated Feb 2, 2004) |
| Status | Terminated |
| Reason | If the drain tube is assembled incorrectly, the suction pump will not operate as intended. |
| Root cause | Other |
| Action | 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. |
| Quantity | 2 tube sets |
| Distribution | Texas and Nebraska |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011911 | SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX Richard Wolf Medical Instruments Corp., Sep 17, 2001 |