Z-0513-2025Class II

MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF...

Name: Z-0513-2025 MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-10-16
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-10-16 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of 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... on 2024-10-16. FDA classified it as Class II and gives the reason as "The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0513-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-16
Posted: 2024-11-22
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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
Product code: LRO General Surgery Tray
Reason for recall: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
FDA root cause: Under Investigation by firm
Action: An IMMEDIATE ACTION REQUIRED RECALL notification letter dated 10/16/24 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Upon receipt of your submitted response form, your account will receive over-labels to place unaffected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-216-FGRecall Code: 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 3744 units
Distribution: US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0513-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0508-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22
Z-0509-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22
Z-0510-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22
Z-0511-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22
Z-0512-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22
Z-0513-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22
Z-0514-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22
Z-0515-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)