Agency classClass IIOur severity:High FDA (Devices)·Z-0514-2025·Announced 2024-12-04

MEDLINE Neuraxial Kit Connectors May Prevent Catheter Insertion

MEDLINE has recalled 360 units of its Neuraxial Kit (Lot 23KLA330) because connectors may not fully open, potentially preventing catheters from being inserted as intended. Healthcare facilities should discontinue use and contact MEDLINE.

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 a Class II medical device recall involving a functional defect in a procedure kit. The connector malfunction poses a risk of harm by preventing proper catheter insertion during neuraxial procedures. However, no injuries or illnesses have been reported, making this a theoretical risk-of-harm scenario. Per the rubric, recalls of risk-of-harm products without reported injuries score at most 3.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling 360 units of its Neuraxial Kit (REF PAIN1876A, Lot 23KLA330) because the kit's connectors may not allow catheters to be inserted properly if the connector is not in the fully open position.

Affected units were distributed nationwide in the US, as well as to Bermuda, Canada, Panama, the UAE, and the US Virgin Islands. The issue poses a risk of improper catheter insertion, which could compromise the intended medical procedure.

Healthcare facilities that have received affected kits should cease use immediately and contact MEDLINE INDUSTRIES, LP for instructions on returning the recalled units or receiving replacements.

The recalled product

Product: MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Procedure Kit
Hazard: device-malfunction
insertion-failure
Affected units: 360

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 (2)

Codes: 1) PAIN1876A UDI-DI: 10195327433666 (each) 40195327433667 (case)
Lot Number: 23KLA330

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 8 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.

See all 8 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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