Date Initiated by Firm | July 09, 2024 |
Date Posted | September 12, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-3128-2024 |
Recall Event ID |
95152 |
510(K)Number | K120988 |
Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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Product | Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 |
Code Information |
GTIN 20613994879329, Lot Numbers: 2023090954, 202312C065 |
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 | During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312). |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Medtronic issued an Urgent: Medical Device Recall notice to its consignees on 07/09/2024 via UPS. The notice explained the issue, potential risk, and requested return of the affected device. Those who further distributed the device were directed to share the notice with those to whom the affected product was distributed. |
Quantity in Commerce | 290 units |
Distribution | Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam. |
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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