Medical Convenience Kits with Defective Plastic Syringes Recalled
Medline Industries recalls medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose risks to patient health. About 1.6 million units were 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 recall with no reported injuries or illnesses. The identified hazards—leaks, breakage, and quality issues in medical syringes—pose theoretical risk to patient health but no actual harm has been documented, fitting the criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling medical convenience kits that contain plastic syringes. Approximately 1,679,067 units have been distributed worldwide under multiple product codes and lot numbers.
The recall was issued following an FDA Safety Alert dated March 19, 2024. The syringes have been identified with leaks, breakage, and other quality issues that may pose a risk to patient health and safety.
The affected kits have been distributed worldwide to hospitals, clinics, medical facilities, and other healthcare settings. Healthcare providers should consult the affected lot numbers and product codes listed in the FDA recall notice for specific guidance on their inventory.
The recalled product
- Product
- See RES Description
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Syringes
- Hazard
- syringe-defect
- leakage
- breakage
- quality-issue
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)
- DYNJ0708470K
- Lot Number 19ALA269
- Lot Number 19ELA237
- Lot Number 19FLA396
- Lot Number 19GLA166
- Lot Number 19HLA649
- Lot Number 19ILA054
- Lot Number 19JLA505
- Lot Number 19KLA167
- Lot Number 19LLA455
- DYNJ0844004
- Lot Number 19AKB795
- Lot Number 19DKC239
- Lot Number 19EKB799
- Lot Number 19FKB763
- Lot Number 19GKB309
- Lot Number 19HKC027
- Lot Number 19IKB582
- Lot Number 19JKB630
- Lot Number 19KKB713
Distribution
Distribution scope not specified by the agency.
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