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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Category
- Medical Device — Procedural Kits
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.
Part of a larger recall action
This product is one of 27 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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