The Recall Desk
HighFDA (Devices)·Z-2751-2024·Announced 2024-09-04

Medline Procedural and Medical Kits Recalled for Defective Syringes

Medline is recalling procedural kits worldwide containing plastic syringes with identified leaks and breakage. The defective syringes were identified in an FDA Safety Alert from March 19, 2024, and may pose risks to patients.

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 of medical devices with actual quality defects (leaks, breakage) identified. The recalled syringes present a risk of harm to patients in clinical settings. No illnesses or injuries have been reported, fitting the criterion for Score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling medical convenience kits containing plastic syringes identified in an FDA Safety Alert issued March 19, 2024. These kits are distributed worldwide and include multiple procedural and medical configurations.

The recalled syringes have experienced identified leaks, breakage, and other quality issues. These defects may pose a risk to patient health based on FDA findings.

No illnesses or injuries have been reported to date in connection with these defective syringes. The recall covers a wide range of medical kits used in various clinical procedures.

The recalled product

Product
Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417A; 3) DRAWER 9L , Pack Number ACC010427A; 4) MEDICATION DELIVERY MODULE, Pack Number ACC010605 ; 5) DRAWER 3, Pack Number
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • leakage
  • breakage
  • syringe-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)

  • ACC010417
  • Lot Numbers: 21JDC136
  • Lot Numbers: 21LDA261
  • Lot Numbers: 22BDA205
  • Lot Numbers: 22FDB645
  • ACC010417A
  • Lot Numbers: 23GDA903
  • Lot Numbers: 23HDA001
  • Lot Numbers: 23HDB495
  • Lot Numbers: 23IDA233
  • Lot Numbers: 23IDB522
  • Lot Numbers: 23JDB187
  • ACC010427A
  • Lot Numbers: 23EDA979
  • Lot Numbers: 23IDB947
  • ACC010605
  • Lot Numbers: 22LDB120
  • Lot Numbers: 23ADB200
  • Lot Numbers: 23ADB656
  • Lot Numbers: 23BDA934

Distribution

Distribution scope not specified by the agency.