namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710

FDA device recall Z-1430-2025 · posted 2025-03-21 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

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

Action taken

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.

Root cause

Process change control

Status

Open, Classified

Product code

OEQ

Quantity affected

100 units

Distribution

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

Date initiated

2025-02-12

Date posted

2025-03-21

Location

Northfield, IL