5/10 Weck Vista Universal Balloon Open Access Port recall
5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port…
Why was 5/10 Weck Vista Universal Balloon Open Access Port recalled?
Complaints of leakage of insufflation gas through the device.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots Catalog No. 410944 - 01K1200601, 01K1200623, 01L1200355, 01L1200378, 01A1300203, 01D1300412, 01J1200241, 01K1200066, 01K1200622; Catalog No. 410944L - 01J1200219, 01K1200067, 01K1200600, 01L1200056, 01L1200354, 01A1300202, Catalog No. 410944S - 01L1200460, 01K1200619, 01L1200515, 01E1300137; Catalog No. 412944 01J1200241, 01K1200066, 01K1200622; Catalog No. 412944L - 01J1200231, 01K1200597, 01K1200618, 01K1200728, 01A1300178, 01D1300316, 01E1300310, 01E1300436
- Product
- 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port…
- Recalling firm
- Teleflex Medical
- Quantity
- 55,521 total
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.
- Recall date
- April 9, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)