WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries.
Summary
The FDA issued a Class II for WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid by WOM World Of Medicine AG. Reason: Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery.
Details
Source
Device Recall
External ID
Z-2243-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
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
Lot/Code Info: UDI: 04056702003678 Lot Numbers: 4030902, 4030903
Quantity Affected: 1700 units
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
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-24
Company
Ludwigsstadt, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
WOM World Of Medicine AG has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (WOM World Of Medicine AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does WOM World Of Medicine AG have FDA actions?
WOM World Of Medicine AG has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2243-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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