FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0537-04
- 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
- Status
- Terminated
- Initiated
- 2004-02-02
- Posted
- 2004-02-11
- Terminated
- 2004-03-24
- 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
- Lot, serial or model codes
- part number 8170.121 There is no lot number or production code.
- 510(k) numbers
- ["K011911"]
- PMA numbers
- not on file
- Product code
- JOL
- Firm FEI
- 1418479
- Firm city
- Vernon Hills
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28