Z-0537-04

Pump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction pump designed for use with the...

Name: Z-0537-04 Pump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction pump designed for use with the...
Creator: Richard Wolf Medical Instruments Corp.
Published: 2004-02-02
License: https://open.fda.gov/license/

Richard Wolf Medical Instruments Corp. / initiated 2004-02-02 / Terminated

FDA source

Richard Wolf Medical Instruments Corp. began a recall of 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... on 2004-02-02. The reason FDA records is "If the drain tube is assembled incorrectly, the suction pump will not operate as intended". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0537-04
Status: Terminated
Initiated: 2004-02-02
Posted: 2004-02-11
Terminated: 2004-03-24
Recalling firm: Richard Wolf Medical Instruments Corp.
Product: 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
Product code: JOL Catheter And Tip, Suction
Reason for recall: If the drain tube is assembled incorrectly, the suction pump will not operate as intended.
FDA 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 in commerce: 2 tube sets
Distribution: Texas and Nebraska
Product codes and lots: part number 8170.121 There is no lot number or production code.

Product code JOL

K011911Class IISuction Pump for Intracorporeal Ultrasound Lithotripter and Accessories, Model 2207.XxxRichard Wolf Medical Instruments Corp. / cleared 2001-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)