Recalls / —

—#187485

Product

Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.

FDA product code

DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K171979

Affected lot / code info

GTIN 00763000258016, Lot numbers 221102356, Use By 2022-10-09; and 221672011, Use By 2022-10-22

Why it was recalled

Specific lots may have been manufactured with insufficient or incomplete welds.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

Medtronic Perfusion Systems

Address

7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

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.

Timeline

Recall initiated

2021-04-29

Terminated

2023-03-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #187485. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.