NAMIC recallZ-1429-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Feb 12, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
FDA root cause category: Process change control
What the company 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.
Recall details
- Recall number
- Z-1429-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 12, 2025
- Posted by the FDA
- Mar 21, 2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 40 units
- Product code
- DRS
- FDA submissions
- K910764
- Distribution
- Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
Product description
namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
Code information (models, lots, serial numbers)
UDI/DI 10193489064803 (each), 20193489064800 (case), Lot number 0000140054
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NAMIC 70036160Medline Industries, Inc. · Transducer, blood-pressure, extravascular1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K910764 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NAMIC 70030021Navilyst Medical, Inc. · TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96367).
- Z-1428-2025 · Open, Classifiednamic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
- Z-1430-2025 · Open, Classifiednamic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
- Z-1431-2025 · Open, Classifiednamic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST,…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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