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Open, Classified

MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840

FDA Recall Z-0124-2025 · Posted 2024-10-17

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeOEZ
Date Initiated2024-08-28
Product Quantity22 kits

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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