Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
FDA Recall Z-1885-2021 · Posted None
Recalling FirmMedtronic Perfusion Systems
Recall StatusTerminated
Product CodeDWF
Date Initiated2021-04-29
Date Terminated2023-03-20
Product Quantity11 tubing packs
Reason for Recall
Specific lots may have been manufactured with insufficient or incomplete welds.
Firm Action
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
[email protected].
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.