MEDLINE INDUSTRIES, LP - Northfield recalls namic convenience kits labeled as: KIT
Reason for recall
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
Lot / code information
UDI/DI 10193489064803 (each), 20193489064800 (case), Lot number 0000140054
What the firm is doing
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.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1429-2025
- FDA 510(k) clearance · K910764The device's official FDA premarket clearance record
- FDA device classification · DRSOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.2850The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find MEDLINE INDUSTRIES, LP - NorthfieldSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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