| Class 2 Device Recall Medtronic | |
Date Initiated by Firm | March 19, 2024 |
Date Posted | May 10, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1796-2024 |
Recall Event ID |
94274 |
510(K)Number | K810820 |
Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
|
Product | Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001 |
Code Information |
GTIN 00613994575319, Lot Numbers: 2023041320, 2023041323; GTIN 00673978180465, Lot Numbers: 2023041316, 2023041323; GTIN 20613994575313, Lot Numbers: 2023041316, 2023041318, 2023041320, 2023041323, 202305C146, 202305C154
|
Recalling Firm/ Manufacturer |
Medtronic Perfusion Systems 7611 Northland Dr N Brooklyn Park MN 55428-1088
|
For Additional Information Contact | Krystin Hayward 508-261-6512 |
Manufacturer Reason for Recall | Potential for unsealed sterile packing. |
FDA Determined Cause 2 | Process control |
Action | Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties.
For questions, the consignee was directed to contact their Medtronic field representative. |
Quantity in Commerce | 7935 units |
Distribution | Worldwide distribution.
|
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
|
|
|
|