Pressure Monitoring Lines Recalled for Manufacturing Defect in Luer Fittings
Medline Industries is recalling namic medical convenience kits containing Pressure Monitoring Lines with defective female luer fittings manufactured with excess material. The defect could impair device function.
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 medical device recall with a manufacturing defect in pressure monitoring equipment. Although no illnesses or injuries are reported, the defect poses a risk of device malfunction that could impact patient monitoring function.
Plain-English summary
Medline Industries, LP is recalling namic medical convenience kits containing Pressure Monitoring Lines (PMLs) with reference number 600605710. The affected lot is 0000141266, and 100 units were involved in the recall.
The female luer fittings on the Pressure Monitoring Lines were manufactured with excess material near the fluid pathway. This manufacturing defect could impair the proper functioning of the pressure monitoring equipment.
The recalled kits were distributed worldwide, including to the United States, Netherlands, New Zealand, and Slovakia.
The recalled product
- Product
- namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 100
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 10193489070279 (each)
- 20193489070276 (case)
- Lot number 0000141266
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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