Medline Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
Medline has recalled convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose risks to patient health. The recall affects multiple lot numbers distributed worldwide.
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: FDA Class II medical device recall involving defective syringes with leaks and breakage that may compromise medication delivery. The risk-of-harm classification applies despite no reported illnesses or injuries, as defective injection devices pose inherent patient safety risks.
Plain-English summary
Medline Industries, LP is recalling convenience kits labeled with multiple pack numbers (DYNJSYR12CP, 148056, and 150206) that contain plastic syringes. The affected kits have been distributed worldwide.
The syringes in these kits have been identified as defective due to leaks, breakage, and other quality issues related to an FDA Safety Alert issued on March 19, 2024. These issues may pose a risk to patient health by compromising the integrity of medication delivery.
Healthcare facilities and medical professionals who have received these kits should stop using the affected lot numbers: 19ABK425, 19ABK443, 24DMC306, 23LMI229, 23JMH148, 23JMA243, 23IMB662, 23HMG815, and 23LME712. Users should contact Medline Industries for replacement syringes or instructions on proper disposal of the defective units.
No specific illnesses or injuries related to these defective syringes have been reported to the FDA at this time.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056; 3) MSC - JOHN MUIR MC, Pack Number 150206
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Syringes
- 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 (12)
- DYNJSYR12CP
- Lot Number 19ABK425
- Lot Number 19ABK443
- 148056
- Lot Number 24DMC306
- Lot Number 23LMI229
- Lot Number 23JMH148
- Lot Number 23JMA243
- Lot Number 23IMB662
- Lot Number 23HMG815
- 150206
- Lot Number 23LME712
Distribution
Distribution scope not specified by the agency.
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