Teleflex Medical Recalls Weck Vista Universal Cone Open Access Devices
Teleflex Medical is recalling 55,521 Weck Vista Universal Cone Open Access devices due to complaints of insufflation gas leakage.
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 involves a medical device with a functional defect (gas leakage) that poses a risk of harm during use, but the source text does not report any specific 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 55,521 units of the 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. This medical device is an endoscope accessory used to provide access, illumination, and observation or manipulation of body cavities, hollow organs, and canals.
The recall was initiated due to complaints of leakage of insufflation gas through the device. The affected lots are identified by Catalog No. 405933 with lot numbers 01L1200353 and 01F1300080.
The devices were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam. Users should stop using the affected devices and contact Teleflex Medical for further instructions.
The recalled product
- Product
- 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. 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
- Hazard
- 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 (2)
- Lots - Catalog No. 405933 - 01L1200353
- 01F1300080
Distribution
Part of a larger recall action
This product is one of 6 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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