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Terminated

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

FDA Recall Z-0537-04 · Posted 2004-02-11

Recalling FirmRichard Wolf Medical Instruments Corp.
Recall StatusTerminated
Product CodeJOL
Date Initiated2004-02-02
Date Terminated2004-03-24
Product Quantity2 tube sets

Reason for Recall

If the drain tube is assembled incorrectly, the suction pump will not operate as intended.

Firm 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.

Root Cause

Other

Distribution Pattern

Texas and Nebraska

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011911SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXXRichard Wolf Medical Instruments Corp. · 2001-09-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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