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U.S. Department of Health and Human Services

Class 2 Device Recall DLP" Single Stage Venous Cannulae with Right Angle Metal Tip

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 Class 2 Device Recall DLP" Single Stage Venous Cannulae with Right Angle Metal Tipsee related information
Date Initiated by FirmJuly 09, 2024
Date PostedSeptember 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3128-2024
Recall Event ID 95152
510(K)NumberK120988 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
ProductMedtronic 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
For Additional Information ContactMedtronic 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
ActionMedtronic 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 Commerce290 units
DistributionWorldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.
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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