WOM Tube Set for lrrlgatlon, single-use- Intended to… recallZ-2243-2024 · WOM World Of Medicine AG · initiated May 24, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from WOM World Of Medicine AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
FDA root cause category: Process control
What the company is doing
Smith & Nephew Issued Urgent Field Safety Notice (FSN) - MEDICAL DEVICE RECALL WOM reference no.: 2024-0001 via email on 5/24/23. Letter states reason fo recall, health risk and action to take; lnform individuals within your organization who need to be aware of this recall. - Check all stock areas and/or operating room storage to determine if any tube sets with lol numbers from Annex 'l are at your facility, - Dispose of all affected tube sets properly. Confirm this on the customer response form. Return the form to [email protected]. Please send any questions to [email protected]
Recall details
- Recall number
- Z-2243-2024
- Status
- Open, Classified
- Initiated by the company
- May 24, 2024
- Posted by the FDA
- Jul 1, 2024
- Recalling firm
- WOM World Of Medicine AG
- Quantity
- 1700 units
- Product code
- HRX
- FDA submissions
- K062380
- Distribution
- US Nationwide distribution.
Product description
WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01
Code information (models, lots, serial numbers)
UDI: 04056702003678 Lot Numbers: 4030902, 4030903
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Tube set for irrigation, single use T0449-01W.O.M. World of Medicine GmbH · Arthroscope1 recall2 reports
Other devices under the same FDA submission
1 device cleared under K062380 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- GoFlo Pump A127W.O.M. World of Medicine GmbH · Arthroscope3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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