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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V

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  Class 2 Device Recall Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V see related information
Date Initiated by Firm April 29, 2021
Create Date June 16, 2021
Recall Status1 Open3, Classified
Recall Number Z-1891-2021
Recall Event ID 87915
510(K)Number K171979  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Code Information GTIN 00763000499105, Lot numbers 221719701, Use By 2023-01-06; and 221764442, Use By 2023-01-13
Recalling Firm/
Manufacturer
Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Medtronic Customer Service
763-391-9000
Manufacturer Reason
for Recall
Specific lots may have been manufactured with insufficient or incomplete welds.
FDA Determined
Cause 2
Nonconforming Material/Component
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 fieldactions@smiths-medical.com.
Quantity in Commerce 25 tubing packs
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = Medtronic, Inc.
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