Medtronic BB11J14R2 recall
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Why was Medtronic BB11J14R2 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 20763000446516, Lot numbers 22128923, Use By 2022-10-31; and Lot 221815851, Use By 2023-01-18
- Product
- Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 15 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)