The Recall Desk
HighFDA (Devices)·Z-2984-2024·Announced 2024-09-18

Medline medical convenience kits with defective plastic syringes recalled

Medline is recalling medical convenience kits containing plastic syringes with identified quality defects including leaks and breakage. The worldwide-distributed kits may pose a risk 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: This recall meets the 'High' criteria as a risk-of-harm product (medical syringes) with identified defects (leaks and breakage) but no reported patient illnesses or injuries. The FDA Class II classification supports a score below Critical or Severe.

Plain-English summary

Medline Industries is recalling multiple medical convenience kits that contain plastic syringes affected by quality defects. The affected kits have been distributed worldwide to medical facilities.

The recalled syringes are affected by defects identified in an FDA Safety Alert issued on March 19, 2024. The identified defects include leaks, breakage, and other quality issues that may pose a risk to patient health during medical procedures.

The recall covers 14 product pack numbers including Tracheotomy Tray, Tracheostomy kits, Trach Pack, Emergency Trach Tray, and others. Multiple lot numbers have been identified as affected across these product variants. Healthcare facilities should verify their inventory against the affected lot numbers listed by Medline Industries.

The recalled product

Product
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ45495G ; 3) TRACH PACK, Pack Number DYNJ46518G ; 4) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007A ; 5) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007B
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • leaks
  • 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 (20)

  • DYNDA1894
  • Lot Number 21HBD322
  • Lot Number 21HBF874
  • Lot Number 21IBL847
  • Lot Number 21JBM308
  • Lot Number 21KBS529
  • Lot Number 19ABT326
  • Lot Number 22CBG860
  • Lot Number 19BBD317
  • Lot Number 19CBV464
  • Lot Number 22JBO787
  • Lot Number 23CBL463
  • Lot Number 23JBP440
  • Lot Number 23KBX335
  • Lot Number 20LBS038
  • Lot Number 21BBO392
  • Lot Number 24ABL991
  • DYNJ46518G
  • Lot Number 21KBO731
  • Lot Number 21LBN631

Distribution

Distribution scope not specified by the agency.