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Recall Observatory FDA recall evidence

Device 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

Z-0513-2025

October 16, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95615
Status
Ongoing
Classification
Class II
Quantity
3744 units
Official record key
device-enforcement:Z-0513-2025

Official wording

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

Code information: 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

Distribution pattern: US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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