Teleflex Medical Recalls Weck Vista Universal Cone Open Access Devices
Teleflex Medical is recalling 55,521 Weck Vista Universal Cone Open Access devices 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 FDA Class II. The hazard involves a functional defect (gas leakage) that causes difficulty or delay in surgery, 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 the 5/10/12MM X 100MM Weck Vista Universal Cone Open Access device. This medical device is used to provide access, illumination, and observation or manipulation of body cavities, hollow organs, and canals 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 product code is 405912R, and the affected lot numbers are 01H1200064, 01K1200378, 01K1200621, 01L1200370, 01M1200071, 01M1200252, 01A1300170, 01A1300201, 01A1300420, 01A1300545, and 01F1300136. Healthcare facilities should stop using these devices and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- 5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, 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 (12)
- Product Code: 405912R
- Lot Numbers: 01H1200064
- 01K1200378
- 01K1200621
- 01L1200370
- 01M1200071
- 01M1200252
- 01A1300170
- 01A1300201
- 01A1300420
- 01A1300545
- and 01F1300136.
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