Medline Namic Convenience Kits Pressure Monitoring Lines Recalled for Manufacturing Defect
Medline is recalling 4400 Namic convenience kits with Pressure Monitoring Lines because the female luer fittings were manufactured with excess material near the fluid pathway.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries or illnesses. The manufacturing defect in the pressure monitoring line fittings poses a risk of harm, meeting the criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling 4400 Namic convenience kits labeled as PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722. These medical convenience kits include Pressure Monitoring Lines (PMLs) that contain a manufacturing defect.
The female luer fittings on the Pressure Monitoring Lines were manufactured with excess material near the fluid pathway. This defect affects the integrity of the fluid pathway connection.
The affected units were distributed worldwide to the United States, Netherlands, New Zealand, and Slovakia. The recall involves Lot number 0000140528, identified by UDI/DI 10193489067507 (individual unit) or 20193489067504 (case).
Patients and healthcare providers using these kits should discontinue use. Affected facilities should identify and quarantine the involved lot and contact Medline Industries for instructions on replacement or return.
The recalled product
- Product
- namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 4,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 10193489067507 (each)
- 20193489067504 (case)
- Lot number 0000140528
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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