Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage
Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports because complaints were received regarding leakage of insufflation gas, which can delay surgical procedures.
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 (difficulty or delay in surgery) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Teleflex Medical is recalling 55,521 units of the Weck Vista Universal Laparoscopic Port, available in 5mm, 10mm, and 12mm sizes. The device is used to provide access, illumination, and observation of body cavities during laparoscopic surgical procedures.
The recall was initiated after complaints were received regarding the leakage of insufflation gas through the device. This leakage can cause difficulty or delay in the completion of laparoscopic surgical procedures.
The affected products were distributed worldwide, including in the United States (nationwide and Puerto Rico), Australia, Brazil, China, Canada, Malaysia, Korea, Ireland, Singapore, and Vietnam. The specific lot numbers involved are 01J1200416, 01K1200612, 01L1200160, 01A1300418, 01A1300427, 01E1300056, 01E1300052, and 01E1300055. Healthcare facilities should stop using these devices and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, 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 (9)
- Product Code: 40591213
- Lot Numbers: 01J1200416
- 01K1200612
- 01L1200160
- 01A1300418
- 01A1300427
- 01E1300056
- 01E1300052
- 01E1300055
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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