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.
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 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…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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.
Part of a larger recall action
This product is one of 81 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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