The Recall Desk
HighFDA (Devices)·Z-2741-2024·Announced 2024-09-04

Medline preop nerve block trays recalled for syringe quality defects

Medline is recalling Preop Nerve Block Tray kits worldwide due to plastic syringes with leaks, breakage, and quality defects. These defects were identified in an FDA safety alert and may pose risks to patient health.

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: FDA Class II medical device recall for quality defects in plastic syringes that may leak or break during use. The defects pose potential health risk to patients during procedures, but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score 3 (High).

Plain-English summary

Medline Industries, LP is recalling Preop Nerve Block Tray procedural kits (Pack Number DYNJRA2040H) sold worldwide. These kits contain plastic syringes affected by quality defects identified in an FDA Safety Alert issued March 19, 2024, including leaks, breakage, and other quality issues.

These defects may pose a risk to patient health during nerve block procedures. The recall affects five specific lot numbers: 23CBH893, 23HBX547, 23JBN538, 24ABQ696, and 24CBG746.

Healthcare providers using these kits should verify lot numbers in their inventory. Those with affected kits should contact Medline Industries for information regarding replacements or next steps.

The recalled product

Product
Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • leakage
  • breakage
  • quality-defect

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 (6)

  • DYNJRA2040H
  • Lot Number 23CBH893
  • Lot Number 23HBX547
  • Lot Number 23JBN538
  • Lot Number 24ABQ696
  • Lot Number 24CBG746

Distribution

Distribution scope not specified by the agency.