Teleflex Medical Recalls Weck Vista Universal Cannula Due to Gas Leakage
Teleflex Medical is recalling 5/10 mm Weck Vista Universal Cannulas because they may leak insufflation gas, potentially delaying laparoscopic surgeries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (delayed surgical procedures) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling 5/10 mm Weck Vista Universal Cannulas. The recall involves 55,521 units distributed worldwide, including the United States, Puerto Rico, and several international markets. The specific product code is 410944, and the affected lot numbers are 01K1200601, 01K1200623, 01L1200355, 01L1200378, 01A1300203, 01D1300412, 01J1200241, 01K1200066, and 01K1200622.
The recall was initiated after complaints were received regarding leakage of insufflation gas through the device. This defect can cause difficulty or delay in the completion of laparoscopic surgical procedures. The device is used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Healthcare facilities and distributors should stop using the affected cannulas and contact Teleflex Medical for instructions on how to return or dispose of the product. No specific instructions for individual consumers are provided in the source text, as the product is a medical device used in surgical settings.
The recalled product
- Product
- 5/10 mm Weck¿, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
- Manufacturer
- Teleflex Medical
- Affected units
- 55,521
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Product Code: 410944
- Lot Numbers: 01K1200601
- 01K1200623
- 01L1200355
- 01L1200378
- 01A1300203
- 01D1300412
- 01J1200241
- 01K1200066
- 01K1200622
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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