—#212653

Product

namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit

FDA product code: DRI — Monitor, Line Isolation
Device class: Class 1
Medical specialty: Cardiovascular
Affected lot / code info: UDI/DI 10193489067507 (each), 20193489067504 (case), Lot number 0000140528

Why it was recalled

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

Root cause (FDA determination)

Process change control

Action the firm took

Medline Industries issued two notices, delivered using email and US Mail: 1) a MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines and 2) a MEDICAL DEVICE RECALL notice for the kits containing the affected product; both notices explained the issue and the hazard. The MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines requested that the consignee destroy any affected inventory and reply to receive credit. The MEDICAL DEVICE RECALL notice for the kits containing the affected product requested the consignee respond to the notice and upon response, Medline will provide labeling that states the following: "ATTENTION This kit contains a recalled item Medline Pressure Monitoring Lines VPN: 24614303 DO NOT USE THIS COMPONENT The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*" Consignees were directed to notify their customers of these actions.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia

Timeline

Recall initiated: 2025-02-12
Posted by FDA: 2025-03-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212653. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.