Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Check against the official notice below — it lists the full affected range.
Medtronic is recalling Medtronic DxTerity TRA 5F Diagnostic Catheters (model U5TRAN35) because the French size indicator printed on the inner pouch may incorrectly show "6 French" instead of the correct "5 French" size. However, the actual catheters inside the pouch are the correct 5 French size, the outer carton labeling is correct, and all other information and configuration details on both the carton and pouch are accurate. The recalled products were distributed to California, Iowa, Nebraska, Tennessee, Texas, Virginia, Washington, Jamaica, New Zealand, and Thailand, with 250 units affected under lot number 60068186.
The recall notice does not specify a remedy or corrective action for consumers who have received this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand Quantity: 250 units Lot/code info: UDI/GTIN: 20643169738717 Lot Number 60068186
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.