Medline CYSTO PACK Convenience Kits Recalled for Defective Syringes
Medline is recalling CYSTO PACK convenience kits containing defective plastic syringes with leaks and breakage that may risk patient health. Affected worldwide; specific lot numbers provided.
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 of medical devices with identified defects (leaks, breakage) in syringes referenced in an FDA Safety Alert. No illnesses or injuries have been reported, but the defects constitute a concrete risk-of-harm product where injury has not yet occurred.
Plain-English summary
Medline Industries is recalling CYSTO PACK convenience kits (Pack Numbers DYNJ42742D and DYNJ42799) that contain plastic syringes. These kits have been distributed worldwide.
The recalled syringes are affected by an FDA Safety Alert issued on March 19, 2024. Identified quality defects include leaks, breakage, and other issues that may pose a risk to patient health.
Users who have received affected kits should stop using them. The recall includes multiple lot numbers for both pack numbers. Consumers should contact Medline Industries with their specific lot number for replacement or further instructions.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-defect
- leakage
- breakage
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)
- DYNJ42742D
- Lot Number 19ABF928
- Lot Number 19BBC938
- Lot Number 19PBB060
- Lot Number 19GBO530
- Lot Number 19HBH965
- Lot Number 19HBJ692
- DYNJ42799
- Lot Number 21GBH529
- Lot Number 19CBO493
- Lot Number 19EBF614
- Lot Number 19FBD772
- Lot Number 19GBE887
- Lot Number 19HBI404
- Lot Number 19IBT472
- Lot Number 20ABD578
- Lot Number 20CBF124
- Lot Number 20DBC424
- Lot Number 20EBT962
- Lot Number 20JBF487
Distribution
Distribution scope not specified by the agency.
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