Date Initiated by Firm | August 28, 2024 |
Date Posted | October 17, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0120-2025 |
Recall Event ID |
95393 |
Product Classification |
Cardiovascular procedure kit - Product Code OEZ
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Product | MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J |
Code Information |
UDI/DI 40195327563784 (case), 10195327563783 (each), Lot Numbers: 24BMD381, 24BMJ452
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Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield 3 Lakes Dr Northfield IL 60093-2753
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For Additional Information Contact | Haley Barclay 866-359-1704 |
Manufacturer Reason for Recall | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Medline issued an UREGENT MEDICAL DEVICE NOTIFICATION to its consignees on 08/28/2024 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the consignee quarantine the product and response to obtain labeling to be placed on the affected inventory. Distributors are directed to notify those to whom they shipped the affected product. |
Quantity in Commerce | 60 kits |
Distribution | US Nationwide distribution. |
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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