CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report

Medline procedure kits labeled as follows: Cont Epi W/Hustead recalled

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure kits labeled as follows: Cont Epi W/Hustead, distributed nationwide in the US. The recall was initiated on 16 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCodes: 1) PAIN1069B UDI-DI: 10889942757381 (each) 40889942757382 (case), Lot Numbers: 22GLA433, 23CLA257; 2) PAIN1941 UDI-DI: 10195327365417 (each) 40195327365418(case), Lot Numbers: 23ELB081; 3) PAIN9023 UDI-DI: 10889942448715(each) 40889942448716 (case), Lot Numbers: 22GLA470, 22ILA287; 4) PAIN1281 UDI-DI: 10888277748408(each) 40888277748409(case), Lot Numbers: 22FLA647; 5) PAIN9024 UDI-DI: 10889942448708(each) 40889942448709(case), Lot Numbers: 22FLA675, 22GLA241, 22HLB225, 22ILA288

Quantity recalled3744 units

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-0513-2025
FDA event ID: 95615
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 16 Oct 2024
FDA classified: 22 Nov 2024
Reported: 4 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

16 Oct 2024	Recall initiated by company
22 Nov 2024	Classified by FDA	+37 days
4 Dec 2024	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 connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN9024

Where it was distributed

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

Nationwide

Questions about this recall

Is Medline procedure kits labeled as follows: Cont Epi W/Hustead recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline procedure kits labeled as follows: Cont Epi W/Hustead on 16 Oct 2024. The recall is Class II and its status is Ongoing. Recall number Z-0513-2025.

Why was it recalled?

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Which lots are affected?

Codes: 1) PAIN1069B UDI-DI: 10889942757381 (each) 40889942757382 (case), Lot Numbers: 22GLA433, 23CLA257; 2) PAIN1941 UDI-DI: 10195327365417 (each) 40195327365418(case), Lot Numbers: 23ELB081; 3) PAIN9023 UDI-DI: 10889942448715(each) 40889942448716 (case), Lot Numbers: 22GLA470, 22ILA287; 4) PAIN1281 UDI-DI: 10888277748408(each) 40888277748409(case), Lot Numbers: 22FLA647; 5) PAIN9024 UDI-DI: 10889942448708(each) 40889942448709(case), Lot Numbers: 22FLA675, 22GLA241, 22HLB225, 22ILA288

Where was it sold?

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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