Medtronic 1A46R11 recall
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
Why was Medtronic 1A46R11 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 00643169947436, Lot number 221387901, Use By 2022-12-16
- Product
- Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 7 tubing sets
- 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)