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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4

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  Class 2 Device Recall Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4 see related information
Date Initiated by Firm April 29, 2021
Create Date June 16, 2021
Recall Status1 Terminated 3 on March 20, 2023
Recall Number Z-1875-2021
Recall Event ID 87915
510(K)Number K171979  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
Code Information GTIN 00643169981102, Lot numbers 220866430, Use By 2022-04-03; 221102361, Use By 2202-04-03; and 221727287, Use By 2022-09-29.
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 27 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = Medtronic, Inc.
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