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U.S. Department of Health and Human Services

Class 2 Device Recall Medline HEART OVERHEAD TABLE PACK

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 Class 2 Device Recall Medline HEART OVERHEAD TABLE PACKsee related information
Date Initiated by FirmAugust 28, 2024
Date PostedOctober 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0120-2025
Recall Event ID 95393
Product Classification Cardiovascular procedure kit - Product Code OEZ
ProductMEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
Code Information UDI/DI 40195327563784 (case), 10195327563783 (each), Lot Numbers: 24BMD381, 24BMJ452
Recalling Firm/
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley 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
ActionMedline 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 Commerce60 kits
DistributionUS Nationwide distribution.
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.
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