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U.S. Department of Health and Human Services

Class 2 Device Recall DLP Vessel Cannula

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  Class 2 Device Recall DLP Vessel Cannula see related information
Date Initiated by Firm February 07, 2024
Date Posted March 19, 2024
Recall Status1 Open3, Classified
Recall Number Z-1316-2024
Recall Event ID 94068
510(K)Number K810820  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic DLP Vessel Cannula, Model Number REF 30000
Code Information UDI/DI 20613994646211, Lot Numbers: 2023020890, 202305C126, 2023020889
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Medtronic Customer Service
800-854-3570
Manufacturer Reason
for Recall		 Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
FDA Determined
Cause 2		 Packaging change control
Action Medtronic Cardiac Surgery issued an Urgent: Medical Device Recall to its consignees on 02/07/2024 via UPS. The notice explained the issue, potential risk, and requested consignees identify and quarantine affected product, and arrange to return the affected product by contacting customer service at 1-800-854-3570, option 1, then Option 4. The notification should be shared with others in your organization as appropriate. If product was forwarded to another facility, please notify the facility of this Medtronic Urgent Medical Device Recall.
Quantity in Commerce 4343 units
Distribution US and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK
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 = DLP, INC.
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