Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
This recall has been terminated (originally issued April 29, 2021).
- Company
- Medtronic Perfusion Systems
- Recall Initiated
- April 29, 2021
- Terminated
- March 20, 2023
- Recall Number
- Z-1880-2021
- Quantity
- 12 tubing packs
- Firm Location
- Brooklyn Park, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Specific lots may have been manufactured with insufficient or incomplete welds.
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.
Lot / Code Info
GTIN 00763000235147, Lot number 221196141, Use By 2022-08-19
Root Cause
Nonconforming Material/Component
Action Taken
Medtronic notified customers by letters dated April 202, via 2-day UPS delivery to consignees explaining the reason for recall and requesting they immediately identify and quarantine all unused product in their inventory. The product was to be returned. A Customer Confirmation Certificate was enclosed for completion via scan and email. If product was further distributed or transferred, the consignee was requested to notify those downstream customers or facilities of the recall. For questions regarding this notification, customers were instructed to contact Smiths Medical via email at fieldactions@smiths-medical.com.