Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Port
Teleflex Medical is recalling 55,521 units of the Weck Vista Universal Balloon Open Access Port due to reported 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 High because it involves a medical device defect that poses a risk of harm (difficulty or delay in surgery) without reported injuries or fatalities, fitting the rubric 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 Weck Vista Universal Balloon Open Access Port - Long Length (100mm). The device is an endoscope accessory used to provide access, illumination, and observation of body cavities and hollow organs during surgical 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 affected product was distributed worldwide, including the United States (nationwide and Puerto Rico), Australia, Brazil, China, Canada, Malaysia, Korea, Ireland, Singapore, and Vietnam. The specific product code is 410944L, and the affected lot numbers are 01J1200219, 01K1200067, 01K1200600, 01L1200056, 01L1200354, and 01A1300202.
The recalled product
- Product
- 5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), 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 (7)
- Product Code: 410944L
- Lot Numbers: 01J1200219
- 01K1200067
- 01K1200600
- 01L1200056
- 01L1200354
- and 01A1300202.
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.
See all 15 products in this recall →Related recalls
Same manufacturer · Teleflex Medical
See all →- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- ModerateTeleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
Same hazard · gas leakage
See all →- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- HighIntersurgical Smoothbore Breathing System Recalled for Incorrect Exhalation Port
FDA (Devices) · 2021-01-06
- SevereTeleflex Medical Recalls Taut Intraducers Due to Gas Leakage Risk
FDA (Devices) · 2015-11-25
- CriticalMaquet FLOW-i Anesthesia System Recalled for Gas Leakage Risk
FDA (Devices) · 2015-06-17
- HighTeleflex Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage
FDA (Devices) · 2014-04-09