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U.S. Department of Health and Human Services

Class 2 Device Recall DLP Pressure Monitoring Extension Line Adapters

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  Class 2 Device Recall DLP Pressure Monitoring Extension Line Adapters see related information
Date Initiated by Firm June 22, 2017
Date Posted July 10, 2017
Recall Status1 Terminated 3 on July 22, 2020
Recall Number Z-2767-2017
Recall Event ID 77641
510(K)Number K831591  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product DLP Pressure Monitoring Extension Line Adapters
Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Code Information Model No. 25009; Product UPN 20613994918608; Lot No. 2016090217, 2016091068, 2016100893, 2016110439, 2016120464, 2017010278, 2017030102, 2017030576, 2017031125.  Model No. 25010: Product UPN 20613994918585: Lot No. 2016020841, 2016031522, 2016050255, 2016070494, 2016081243, 2016090923, 2016110054, 2016110837, 2017040714. 
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Joey Lomicky
763-526-2494
Manufacturer Reason
for Recall		 Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
FDA Determined
Cause 2		 Packaging process control
Action Medtronic sent an Urgent Medical Device Recall letter dated June 22, 2017, to all affected consignees, both in the US, via 2-Day UPS Mail, and OUS, via local methods. Consignees were asked to quarantine and return any affected product. No recommendations were made for patients who have undergone procedures using affected product. US consignees were asked to complete and return a recall notification confirmation certificate to fax 651-367-0612, indicating that they were informed of the recall and executed the appropriate action. Customers with questions were instructed to contact Customer Service at 1-800-854-3570. For questions regarding this recall call 763-526-2494.
Quantity in Commerce 63053 (48180 US) (14873 OUS)
Distribution Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.
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 = DLP, INC.
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