Reported Oct 3, 2018 · Terminated
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Medtronic Vascular
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Vascular · 35-37A Cherry Hill Drive · Danvers, MA · 01923-2565
Is this the product you have?
Medtronic DxTerity(TM) TRA 5FDiagnostic CatheterREF U5TRAN35
- Lot codes and dates
- UDI/GTIN20643169738717 Lot Number 60068186
- Amount recalled
- 250 units
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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