| Class 2 Device Recall DLP Antegrade/Retrograde Adapter | |
Date Initiated by Firm | June 22, 2017 |
Date Posted | July 10, 2017 |
Recall Status1 |
Terminated 3 on July 22, 2020 |
Recall Number | Z-2765-2017 |
Recall Event ID |
77641 |
510(K)Number | K900994 |
Product Classification |
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
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Product | DLP Antegrade/Retrograde Adapter
Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae |
Code Information |
Model No. 13001; Product UPN 20613994677611; Lot No. 2016020795, 2016030222, 2016030813, 2016031019, 2016040411, 2016040614, 201604C004, 2016050516, 2016050769, 2016051176, 2016060227, 2016061042, 2016061440, 2016070193, 2016070921, 2016070922, 2016080373, 2016090545, 2016091365, 2016100614, 2016101189, 2016101190, 2016110125, 2016110825, 2016111024, 2016111026, 201612C046, 2017010914, 2017010915, 2017020855, 2017020856, 2017021022, 201702C012, 2017030536, 2017031116, 2017040101. |
Recalling Firm/ Manufacturer |
Medtronic Perfusion Systems 7611 Northland Dr N Brooklyn Park MN 55428-1088
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DTL
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