FDA-Device2018-10-03Class III
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Medtronic Vascular
Hazard
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.
Sold states
CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand
Affected count
250 units
Manufactured in
35-37A Cherry Hill Drive, Danvers, MA, United States
Products
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3253-2018Don't want to check this manually?
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