CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report
namic convenience kits labeled as: KIT,Arterial,60,PG recalled
Medline Industries LP - Northfield is recalling namic convenience kits labeled as: KIT,Arterial,60,PG; medical convenience kit, distributed nationwide in the US. The recall was initiated on 12 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1429-2025
- FDA event ID
- 96367
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Feb 2025
- FDA classified
- 21 Mar 2025
- Reported
- 2 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Feb 2025 | Recall initiated by company | |
| 21 Mar 2025 | Classified by FDA | +37 days |
| 2 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Product as listed by the FDA
namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
Where it was distributed
Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
Questions about this recall
Why was it recalled?
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Which lots are affected?
UDI/DI 10193489064803 (each), 20193489064800 (case), Lot number 0000140054
Where was it sold?
Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 96367This product is part of a recall event; the main page for the event is namic convenience kits labeled as: Mts,4 Valve,Lft,Hrt,Kit-ahs-a*,NW recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | namic convenience kits labeled as: Mts,4 Valve,Lft,Hrt,Kit-ahs-a*,NW recalled | Medline Industries LP - Northfield | Other | Nationwide | |
| CLASS II | namic convenience kits labeled as: Pml,72,Adult,Fll-mll,-,Oem recalled | Medline Industries LP - Northfield | Other | Nationwide | |
| CLASS II | namic convenience kits labeled as recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Other | Nationwide |
More recalls from Medline Industries LP - Northfield
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|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
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| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |