Teleflex Medical Recalls Weck Vista Cannulas Due to Gas Leakage
Teleflex Medical is recalling 55,521 units of 10mm and 12mm Weck Vista Cannulas because they may leak insufflation gas.
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 (gas leakage) in a medical device used during procedures, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Teleflex Medical is recalling 55,521 units of 10mm Weck Vista Cannula-only (Catalog No. 405910C) and 12mm Weck Vista Cannula-only (Catalog No. 405912C). These devices are 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 include specific catalog numbers and lot codes for both the 10mm and 12mm models.
The products 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
- 10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. 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 (11)
- Lots - Catalog No. 405910C - 01G1200243
- 01J1200226
- 01L1200368
- 01A1300177
- 01D1300107
- 01E1300140
- 01E1300435
- Catalog No. 405912C - 01J1200384
- 01K1200725
- 01L1200352
- 01D1300319
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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