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Terminated

Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.

FDA Recall Z-1882-2021 · Posted None

Recalling FirmMedtronic Perfusion Systems
Recall StatusTerminated
Product CodeDWF
Date Initiated2021-04-29
Date Terminated2023-03-20
Product Quantity12 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.

K171979Tubing PackMedtronic, Inc. · 2017-10-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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