Medtronic HY8M63R4 recall
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Why was Medtronic HY8M63R4 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 00643169921948, Lot #221058527, Use By 2022-10-30
- Product
- Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 2 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)