WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries.
FDA device recall Z-2243-2024 · posted 2024-07-01 · Open, Classified
Recall details
- Recalling firm
- WOM World Of Medicine AG
- Reason for recall
- Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
- Action taken
- 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 fieldactions@smith-nephew.com. Please send any questions to fieldactions@smith-neDhew.com
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HRX
- Quantity affected
- 1700 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-05-24
- Date posted
- 2024-07-01
- Location
- Ludwigsstadt, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLOSIMPLE ARTHROSCOPY PUMP A120 (K062380) | W.O.M. World of Medicine AG | 2006-12-14 |