The Recall Desk
HighFDA (Devices)·Z-0513-2025·Announced 2024-12-04

MEDLINE Epidural and Spinal Procedure Kits: Connector May Prevent Catheter Insertion

MEDLINE is recalling 3,744 epidural and spinal procedure kits due to a connector defect that may prevent proper catheter insertion. Affected kits were distributed nationwide and internationally.

What this means for you

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 FDA Class II recall involving a mechanical connector defect in medical device procedure kits that could prevent proper catheter insertion during epidural or spinal procedures. The source text describes a risk-of-harm situation but does not report any illnesses, injuries, or hospitalizations, placing this in the 'risk-of-harm products where injury has not yet been reported' category per the severity rubric.

Plain-English summary

MEDLINE Industries is recalling 3,744 procedure kits used for epidural and spinal procedures. The affected kits are identified by five product codes: CONT EPI 20G W/HUSTEAD (REF PAIN1069B), CSE TRAY (REF PAIN1941), TRAY CON EPID 20G NYL W/TUOHY (REF PAIN9023), TRAY CONT EPI 20G NYL W/ HUST (REF PAIN1281), and TRAY CONT EPI 20G NYL W/ HUST (REF PAIN9024), with specific lot numbers for each product.

The recall was initiated because the connectors in these kits may not allow catheters to be inserted as intended if the connector is not in the fully open position. This defect could prevent proper catheter placement during epidural or spinal procedures.

The kits were distributed nationwide in the United States and to Bermuda, Canada, Panama, the United Arab Emirates, and the U.S. Virgin Islands. Medical facilities and healthcare professionals who have received these kits should verify which products they possess against the recalled lot numbers and contact MEDLINE Industries for additional information and guidance on returns or replacements.

The recalled product

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
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Epidural and Spinal Procedure Kits
Hazard
  • connector-failure
  • insertion-failure

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 (15)

  • 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

Distributed nationwide across the United States.

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