FDAClass IIJune 23, 2021

Medtronic HY7M07R6 recall

Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.

Why was Medtronic HY7M07R6 recalled?

Specific lots may have been manufactured with insufficient or incomplete welds.

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?

GTIN 00643169981102, Lot numbers 220866430, Use By 2022-04-03; 221102361, Use By 2202-04-03; and 221727287, Use By 2022-09-29.

Product
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
Recalling firm
Medtronic Perfusion Systems
Quantity
27 tubing packs
Distribution
US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
Recall date
June 23, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls