Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Reported: June 23, 2021 Initiated: April 29, 2021 #Z-1892-2021
Product Description
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Reason for Recall
Specific lots may have been manufactured with insufficient or incomplete welds.
Details
- Recalling Firm
- Medtronic Perfusion Systems
- Units Affected
- 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.
- Location
- Brooklyn Park, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.. Recalled by Medtronic Perfusion Systems. Units affected: 2 tubing packs.
Why was this product recalled? ▼
Specific lots may have been manufactured with insufficient or incomplete welds.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 23, 2021. Severity: Moderate. Recall number: Z-1892-2021.
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