Z-1880-2021 Class II Terminated
FDA device recall Z-1880-2021 was initiated by Medtronic Perfusion Systems on April 29, 2021 and is designated Class II. Reason for recall: Specific lots may have been manufactured with insufficient or incomplete welds. The recall status is terminated (terminated March 20, 2023). Affected quantity: 12 tubing packs.
Recall Details
- Product Type
- Devices
- Report Date
- June 23, 2021
- Initiation Date
- April 29, 2021
- Termination Date
- March 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 tubing packs
Product Description
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
Reason for Recall
Specific lots may have been manufactured with insufficient or incomplete welds.
Distribution Pattern
US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
Code Information
GTIN 00763000235147, Lot number 221196141, Use By 2022-08-19