The Recall Desk
HighFDA (Devices)·Z-2635-2024·Announced 2024-09-04

Medline Medical Convenience Kits with Plastic Syringe Defects

Medline is recalling approximately 1.68 million medical convenience kits with plastic syringes affected by leaks and breakage. The defects may pose a risk to patient health per an FDA Safety Alert issued March 19, 2024.

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 qualifies as High (Score 3) because it involves a medical device with identified quality defects (leaks, breakage) that pose a risk of harm to patients, with no reported illnesses or injuries documented in the source text. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling medical convenience kits that contain plastic syringes. The recall affects approximately 1.68 million units that have been distributed worldwide.

The plastic syringes in these kits were affected by an FDA Safety Alert issued on March 19, 2024. Quality issues including leaks, breakage, and other defects have been identified in the syringes. These defects may pose a risk to patient health.

Healthcare providers and facilities should identify whether they have affected kits in their inventory using the product identification information provided by Medline. Those with affected products should contact the manufacturer for guidance on appropriate actions.

The recalled product

Product
Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack Number DYNDA2391; 3) BLOCK KIT , Pack Number DYNDA2508; 4) NERVE BLOCK PAIN PACK, Pack Number DYNDL1389; 5) BLOCK TRAY-LF , Pack Number DYNJ0117039; 6) NER
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • syringe-leak
  • syringe-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)

  • CDS981579O
  • Lot Number 21JBM647
  • Lot Number 21JBQ860
  • Lot Number 22CBX741
  • Lot Number 19EBL586
  • Lot Number 19GBJ538
  • Lot Number 19IBH976
  • Lot Number 19JBZ536
  • Lot Number 19KBB918
  • Lot Number 20ABP061
  • Lot Number 20BBA647
  • Lot Number 20DBM006
  • Lot Number 20FBS525
  • Lot Number 21ABO831
  • Lot Number 21BBI363
  • Lot Number 21CBI409
  • Lot Number 21DBG604
  • Lot Number 21FBC673
  • DYNDA2391
  • Lot Number 21JBR496

Distribution

Distribution scope not specified by the agency.