Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports
Teleflex Medical is recalling 55,521 Weck Vista Universal Balloon Open Access Ports due to gas leakage that may delay 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 (difficulty or delay in surgery) without reported injuries or fatalities, fitting the High severity criteria.
Plain-English summary
Teleflex Medical is recalling 55,521 units of the 5/10/12 Weck Vista Universal Balloon Open Access Port, Standard Length (70mm). The affected product codes are 410944S, and the specific lot numbers are 01J1200460, 01K1200619, 01L1200515, and 01E1300137. This device is used to provide access, illumination, and observation or manipulation of body cavities, hollow organs, and canals during endoscopic procedures.
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 agency has classified this as a Class II recall.
The products 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 and users should stop using the affected devices and contact Teleflex Medical for further instructions.
The recalled product
- Product
- 5/10/12 Weck¿ Vista" Universal Balloon Open Access Port Standard Length (70mm), 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: 410944S
- Lot Numbers: 01J1200460
- 01K1200619
- 01L1200515
- and 01E1300137.
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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