—#210126

Product

MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840

FDA product code: OEZ — Cardiovascular Procedure Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: UDI/DI 40195327185078 (case), 10195327185077 (each), Lot Numbers: 24BMF235

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-08-28
Posted by FDA: 2024-10-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210126. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.