The Recall Desk
HighFDA (Devices)·Z-3027-2024·Announced 2024-09-18

Medline Medical Convenience Kits Recalled for Defective Plastic Syringes

Medline medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues. The affected devices have been distributed worldwide and 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 is an FDA Class II recall with no reported illnesses or injuries. The source describes potential risks to patient health from quality defects in syringes used in medical procedures, making this a risk-of-harm medical device product without confirmed injury, which aligns with severity score 3 per the rubric.

Plain-English summary

Medline medical convenience kits containing plastic syringes affected by an FDA Safety Alert issued on March 19, 2024, are being recalled. The plastic syringes in these kits have experienced leaks, breakage, and other quality issues.

The recall affects multiple types of medical procedural kits, including 6-inch femoral arterial line kits, chest tube insertion trays, port access trays, biopsy kits, dialysis change kits, and other surgical and diagnostic convenience kits. Numerous pack numbers and lot numbers are affected across products manufactured by Medline Industries, LP.

These defects may pose a risk to patient health in clinical settings where reliable syringe performance is critical. The affected kits have been distributed worldwide.

The recalled product

Product
Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 5) PORT TRAY , Pack Nu
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • defective-syringe
  • 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)

  • ART245C
  • Lot Number 2023083090
  • CHT1900
  • Lot Number 2020092590
  • CHT560
  • Lot Number 2020110590
  • CHT705
  • Lot Number 2023011790
  • DT19245
  • Lot Number 21JBN311
  • DYNDA1466A
  • Lot Number 2021111090
  • Lot Number 2023091890
  • DYNDA1733B
  • Lot Number 2019021950
  • DYNDA1814
  • Lot Number 2018103050
  • Lot Number 2018121450
  • Lot Number 2019010950
  • Lot Number 2019041850

Distribution

Distribution scope not specified by the agency.