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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 Cannulasee related information
Date Initiated by FirmFebruary 07, 2024
Date PostedMarch 19, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1316-2024
Recall Event ID 94068
510(K)NumberK810820 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
ProductMedtronic 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 ContactMedtronic 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
ActionMedtronic 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 Commerce4343 units
DistributionUS and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DWF
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