Medtronic DxTerity(TM) TRA 5F recall: Labeling Error
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Why was Medtronic DxTerity(TM) TRA 5F recalled?
Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.
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?
UDI/GTIN: 20643169738717 Lot Number 60068186
- Product
- Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
- Recalling firm
- Medtronic Vascular
- Quantity
- 250 units
- Distribution
- CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand
- Recall date
- October 3, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)