Thin-Flex Venous Cannula recall
Thin-Flex Venous Cannula, Model Number:TF292902A
Why was Thin-Flex Venous Cannula recalled?
Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.
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?
Lot No: 59384061 59677936 59985533 59430941 59723695 59999044 59456603 59746454 60010418 59498228 59779239 60106398 59545464 59846864 60113045 59580433 59883622 60121142 59608030 59931290 60172116 59649580 59963196 60181079
- Product
- Thin-Flex Venous Cannula, Model Number:TF292902A
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 8,915 units
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates , Belgium, Czech Republic, Spain, France, United Kingdom, Italy, Kuwait, Netherlands, Romania, Saudi Arabia, Sweden, Singapore, Thailand and South Africa.
- Recall date
- December 16, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)