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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
Date Initiated by Firm March 19, 2024
Date Posted May 10, 2024
Recall Status1 Open3, Classified
Recall Number Z-1802-2024
Recall Event ID 94274
510(K)Number K113235  
Product Classification Gauge, pressure, coronary, cardiopulmonary bypass - Product Code DXS
Product Medtronic Disposable Pressure Display Sets:
a) DLP¿ 114.3 cm (45 in), Model Number 61000;
b) DLP¿ 114.3 cm (45 in), Model Number 62000
Code Information a) Model Number 61000, GTIN 00643169880955, Lot Numbers: 2023030432, 2023030433; a) Model Number 61000, GTIN 20643169880959, Lot Numbers: 2023030431, 2023030432, 2023030433, 2023030734, 202305C226, 202307C176, 202307C177; b) Model Number 62000, GTIN 20613994846642, Lot Numbers: 2023030223, 2023030736, 2023031580, 202305C225
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Krystin Hayward
508-261-6512
Manufacturer Reason
for Recall		 Potential for unsealed sterile packing.
FDA Determined
Cause 2		 Process control
Action Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.
Quantity in Commerce 1624 units
Distribution Worldwide 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 = DXS and Original Applicant = MEDTRONIC INC.
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