Medtronic Custom Perfusion Pack (Medtronic) – Weld Insufficiency (2021)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Brand
Medtronic Perfusion Systems
Lot Codes / Batch Numbers
GTIN 00763000499105, Lot numbers 221719701, Use By 2023-01-06, and 221764442, Use By 2023-01-13
Products Sold
GTIN 00763000499105, Lot numbers 221719701, Use By 2023-01-06; and 221764442, Use By 2023-01-13
Medtronic Perfusion Systems is recalling Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx. due to Specific lots may have been manufactured with insufficient or incomplete welds.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Specific lots may have been manufactured with insufficient or incomplete welds.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026