Medline Medical Convenience Kits with Syringes Recalled for Leaks and Breakage
Medline Industries recalls 1,679,067 medical convenience kits containing plastic syringes that may leak or break, posing potential risks to patient health.
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 a medical device with potential for harm (leaking or breaking syringes) where no illnesses or injuries have been reported. The hazard is identified but theoretical, matching the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries is recalling medical convenience kits that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The syringes have been identified as having leaks, breakage, and other quality issues that may pose a risk to patient health.
Approximately 1,679,067 units of affected kits have been distributed worldwide. Users of these kits should check whether their products are among the affected lot numbers and follow guidance from Medline Industries or their healthcare provider regarding use and replacement.
The recalled product
- Product
- See RES description
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leakage
- device-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 (20)
- CDS981579O
- Lot Number 21JBM647
- Lot Number 21JBQ860
- Lot Number 22CBX741
- Lot Number 19EBL586
- Lot Number 19GBJ538
- Lot Number 19IBH976
- Lot Number 19JBZ536
- Lot Number 19KBB918
- Lot Number 20ABP061
- Lot Number 20BBA647
- Lot Number 20DBM006
- Lot Number 20FBS525
- Lot Number 21ABO831
- Lot Number 21BBI363
- Lot Number 21CBI409
- Lot Number 21DBG604
- Lot Number 21FBC673
- DYNDA2391
- Lot Number 21JBR496
Distribution
Distribution scope not specified by the agency.
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