| Class 2 Device Recall DLP Vessel Cannula |  |
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
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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
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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 |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = DWF
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