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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-1801-2024
Recall Event ID 94274
510(K)Number K182586  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic Cardioplegia Adapters:
a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,
b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010,
c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003,
d) DLP¿ 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000,
e) DLP¿ 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G,
f) DLP¿ Perfusion/Venting Adapter, Model Number 13002,
g) DLP¿ Y Adapter Coronary Perfusion, Model Number 10710
Code Information a) Model Number 25009, GTIN 20613994918608, Lot Numbers: 2023040212, 202305C110; b) Model Number 25010, GTIN 20613994918585, Lot Numbers: 2023041227, 202305C111; c) Model Number 14003, GTIN 00613994619662, Lot Numbers: 2023040464; c) Model Number 14003, GTIN 20613994619666, Lot Numbers: 2023040463, 2023040464, 202305C102; d) Model Number 14000, GTIN 00613994619716, Lot Numbers: 2023041205, 2023041206; d) Model Number 14000, GTIN 20613994619710, Lot Numbers: 2023041205, 2023041206, 202305C098, 202305C099; e) Model Number 11001G, GTIN 00613994918550, Lot Numbers: 2023031005; e) Model Number 11001G, GTIN 20613994918554, Lot Numbers: 2023030371, 2023030659, 2023031004, 2023031005, 2023031530, 2023040160, 2023040431, 2023040432, 2023040804, 2023040805, 2023041171, 202306C131, 202306C136, 202308C218; f) Model Number 13002, GTIN 20613994756057, Lot Numbers: 2023040459, 202305C097; g) Model Number 10710, GTIN 20613994685937, Lot Numbers: 20613994685937
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 6290 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 = DWF and Original Applicant = Medtronic, Inc.
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