The Recall Desk
HighFDA (Devices)·Z-2987-2024·Announced 2024-09-18

Medline Convenience Kits Recalled for Syringe Leaks and Breakage

Medline is recalling medical convenience kits containing defective plastic syringes that may leak or break. The kits are used for epidural and spinal anesthesia procedures and have been distributed worldwide.

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 recall with no reported illnesses or injuries. The defects present a theoretical risk to patient health, meeting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling medical convenience kits that include plastic syringes with identified defects. The kits are used for epidural and spinal anesthesia procedures and have been distributed worldwide.

The plastic syringes have leaks, breakage, and other quality issues that may pose a risk to patient health. These defects were identified in relation to an FDA Safety Alert issued on March 19, 2024.

The recall affects multiple pack numbers and specific lot numbers of the kits. Detailed product identification information and affected lot numbers are available from the FDA and Medline Industries.

The recalled product

Product
Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ; 2) EPIDURAL CSTM PACK-LF , Pack Number DYNJ0844004; 3) CUSTOM EPIDURAL PACK-LF , Pack Number DYNJ0934752F ; 4) EPIDURAL PACK-LF, Pack Number DYNJ0957053D ; 5) EPIDURAL PACK-LF,
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • device-failure
  • leakage
  • breakage

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 (20)

  • DYNJ0708470K
  • Lot Number 19ALA269
  • Lot Number 19ELA237
  • Lot Number 19FLA396
  • Lot Number 19GLA166
  • Lot Number 19HLA649
  • Lot Number 19ILA054
  • Lot Number 19JLA505
  • Lot Number 19KLA167
  • Lot Number 19LLA455
  • DYNJ0844004
  • Lot Number 19AKB795
  • Lot Number 19DKC239
  • Lot Number 19EKB799
  • Lot Number 19FKB763
  • Lot Number 19GKB309
  • Lot Number 19HKC027
  • Lot Number 19IKB582
  • Lot Number 19JKB630
  • Lot Number 19KKB713

Distribution

Distribution scope not specified by the agency.