The Recall Desk
HighFDA (Devices)·Z-0512-2025·Announced 2024-12-04

MEDLINE Procedure Kits: Connectors May Prevent Intended Catheter Insertion

MEDLINE procedure kits are being recalled because connectors may not allow proper catheter insertion if not fully opened. The recall affects 3006 units distributed in the US 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 an FDA Class II recall involving a risk-of-harm medical device where the connector malfunction could prevent proper catheter insertion. Per the severity rubric, risk-of-harm products where injury has not been reported score 3 (High).

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling three types of procedure kits. The recalled products are PERIPHERAL CONTINUOUS NERVE BLOCK (Ref PAIN1423A), CONTINUOUS 20G EPI MRI COMPATIBLE (Ref PAIN1470A), and EPIDURAL CATHETERIZATION KIT (Ref PAIN1644). Approximately 3006 units have been identified in this recall.

The connectors on these procedure kits may not allow catheters to be inserted as intended if the connector is not in the fully open position. This could prevent the proper use of these medical devices in clinical settings.

The affected kits were distributed throughout the United States and internationally to Bermuda, Canada, Panama, the United Arab Emirates, and the U.S. Virgin Islands. Healthcare providers and facilities should verify whether they have units affected by this recall by checking the product reference numbers. Contact MEDLINE INDUSTRIES, LP with any questions or concerns about the recalled products.

The recalled product

Product
MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Procedure Kits / Anesthesia and Pain Management
Hazard
  • connector-malfunction
  • 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 (19)

  • Codes: 1) PAIN1423A UDI-DI: 10193489201826 (each) 40193489201827 (case)
  • Lot Numbers: 22GLA530
  • 23BLA921
  • 23DLA373
  • 23GLA522
  • 23ILA136
  • 23JLB217
  • 23KLA008
  • 2) PAIN1470A UDI-DI: 10193489957365 (each) 40193489957366 (case)
  • Lot Numbers: 21JLA366
  • 21JLA956
  • 21LLA271
  • 22CLA831
  • 22DLA301
  • 22DLB149
  • 22FLA103
  • 3) PAIN1644 UDI-DI: 10193489331141 (each) 40193489331142 (case)
  • Lot Numbers: 22FLA985
  • 23CLA104

Distribution

Distributed nationwide across the United States.

Related recalls

Same category