Teleflex Medical Recalls Weck Vista Universal Cannula Due to Gas Leakage
Teleflex Medical is recalling 55,521 units of 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. The hazard involves a functional defect that causes difficulty or delay in surgical procedures, representing a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Teleflex Medical is recalling 55,521 units of 5/10/12 mm Weck Vista Universal Cannulas. The recall affects specific product code 405912C and lot numbers 01J1200384, 01K1200725, 01L1200352, and 01B1300009.
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 affected devices are used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in Australia, Brazil, China, Canada, Malaysia, Korea, Ireland, Singapore, and Vietnam. Healthcare facilities should stop using the affected devices and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- 5/10/12 mm Weck¿ Vista" Universal Cannula, 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 (5)
- Product Code: 405912C
- Lot Numbers: 01J1200384
- 01K1200725
- 01L1200352
- and 01B1300009.
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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