The Recall Desk
HighFDA (Devices)·Z-2634-2024·Announced 2024-09-04

Medline recalls medical convenience kits with defective plastic syringes

Medline Industries is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and quality issues.

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: The recall involves a medical device with quality issues (leaks, breakage) that may pose a risk to patient health, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling specific medical convenience kits that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The recall covers 1,679,067 units distributed worldwide. The affected products include various pain management, biopsy, and procedure trays and packs, such as Pain Services CDS, Pain Trays, and Epidural Trays, identified by specific pack and lot numbers.

The recall is being conducted because leaks, breakage, and other quality issues have been identified in the plastic syringes contained within these kits. These defects may pose a risk to patient health. The source text does not specify the exact nature of the patient harm or report any specific illnesses or injuries.

Healthcare facilities and consumers should check their inventory for the affected pack and lot numbers listed in the official recall notice. If you have these products, stop using them and contact Medline Industries for instructions on how to return or dispose of the items.

The recalled product

Product
Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Number CDS985445C ; 3) PAIN TRAY , Pack Number DYNDA1233B ; 4) PAIN TRAY , Pack Number DYNDA2402A ; 5) C ARM BLOCK PACK, Pack Number DYNDA2795; 6) SINGLE DOSE E
Affected units
1,679,067

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)

  • CDS985445B
  • Lot Number 19ABK040
  • Lot Number 19ABV498
  • Lot Number 19BBN825
  • Lot Number 19EBG359
  • Lot Number 19FBA393
  • Lot Number 19GBC446
  • Lot Number 19HBM036
  • Lot Number 19JBS476
  • Lot Number 19LBC804
  • Lot Number 20BBA618
  • Lot Number 20CBI761
  • Lot Number 20DBM201
  • Lot Number 21ABX275
  • Lot Number 21CBG480
  • Lot Number 21CBV955
  • Lot Number 21DBQ516
  • CDS985445C
  • Lot Number 21IBP827
  • Lot Number 21KBO008

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 13 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →