The Recall Desk
HighFDA (Devices)·Z-3040-2024·Announced 2024-09-18

Medline Medical Convenience Kits Recalled for Plastic Syringe Defects

Medline is recalling multiple medical convenience kits containing plastic syringes with quality issues including leaks and breakage. These kits are used for chest procedures 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: This is an FDA Class II recall involving quality defects (leaks, breakage) in medical kits used for invasive procedures. No illnesses or injuries have been reported, placing it at the High level where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling 13 medical convenience kits that contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. The affected products include chest tube trays, chest tube insertion trays, pericardial drain kits, bedside thoracentesis kits, and incision and drainage trays distributed worldwide under various pack numbers and lot numbers.

The plastic syringes in these kits have quality defects including leaks and breakage, as well as other unspecified quality issues. These defects may pose a risk to patient health when the kits are used in medical procedures.

Healthcare facilities and medical professionals using these kits should identify affected products using the provided lot and pack numbers.

The recalled product

Product
Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2941A ; 4) PERICARDIAL DRAIN KIT , Pack Number DYNDA2998; 5) KIT, BEDSIDE THORACENTESIS
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • syringe-leak
  • syringe-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)

  • CHT2120
  • Lot Number 23DLA374
  • Lot Number 23ELA871
  • Lot Number 23FLA655
  • DYNDA2475
  • Lot Number 22IMA813
  • DYNDA2941A
  • Lot Number 23BMB940
  • Lot Number 23FMF503
  • DYNDA2998
  • Lot Number 22KBB005
  • Lot Number 23BBD525
  • DYNDH1794
  • Lot Number 22LBM374
  • Lot Number 23EBL615
  • Lot Number 23LMF847
  • DYNDH1794H
  • DYNJ04474F
  • Lot Number 22JLA750
  • Lot Number 23BLA545

Distribution

Distribution scope not specified by the agency.