5/10 Weck¿ Vista" Universal Balloon Open Access Port recall
5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide…
Why was 5/10 Weck¿ Vista" Universal Balloon Open Access Port recalled?
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
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?
Product Code: 410944L, Lot Numbers: 01J1200219, 01K1200067, 01K1200600, 01L1200056, 01L1200354, and 01A1300202.
- 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…
- Recalling firm
- Teleflex Medical
- Quantity
- 55,521 ea. in total
- Distribution
- Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.
- Recall date
- April 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)