Medline Arterial Pressure Monitoring Line Kits Recalled for Manufacturing Defect
Medline is recalling certain arterial pressure monitoring line kits due to excess material on female luer fittings. The affected kits were distributed worldwide, including the United States.
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: FDA Class II recall with no reported adverse events. The manufacturing defect in the pressure monitoring line fittings represents a risk-of-harm product where injury has not yet been reported, meeting the criterion for High severity.
Plain-English summary
Medline Industries, LP is recalling certain namic arterial pressure monitoring line (PML) kits due to a manufacturing defect. The female luer fittings on the affected kits were manufactured with excess material near the fluid pathway.
The recall affects 40 units of the namic arterial convenience kit (REF 70036160) with Lot number 0000140054. These kits were distributed worldwide, including throughout the United States, and to customers in the Netherlands, New Zealand, and Slovakia.
Customers who have received affected kits should contact Medline Industries for instructions on replacement or disposal.
The recalled product
- Product
- namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 40
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 10193489064803 (each)
- 20193489064800 (case)
- Lot number 0000140054
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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