Medical Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage
Medline Industries is recalling over 1.6 million medical convenience kits containing plastic syringes that may leak or break, posing a potential risk to patient safety. The affected kits are 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: This is an FDA Class II recall of syringes with documented quality defects (leaks and breakage) that could potentially harm patients. However, no illnesses or injuries have been reported in the source. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' warranting a High severity score.
Plain-English summary
Medline Industries, LP is recalling medical convenience kits containing plastic syringes. The kits are distributed worldwide, with approximately 1.6 million units identified in this recall.
Leaks, breakage, and other quality issues have been identified in the plastic syringes contained in these kits. These issues are referenced in an FDA Safety Alert issued on March 19, 2024, and may pose a risk to patient health.
Specific lot numbers and product codes for the affected kits are documented in the official FDA recall notice.
The recalled product
- Product
- see RES for description
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Syringes
- Hazard
- leaks
- 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)
- CDS985445B
- Lot Number19ABK040
- Lot Number19ABV498
- Lot Number19BBN825
- Lot Number19EBG359
- Lot Number19FBA393
- Lot Number19GBC446
- Lot Number19HBM036
- Lot Number19JBS476
- Lot Number19LBC804
- Lot Number20BBA618
- Lot Number20CBI761
- Lot Number20DBM201
- Lot Number21ABX275
- Lot Number21CBG480
- Lot Number21CBV955
- Lot Number21DBQ516
- CDS985445C
- Lot Number21IBP827
- Lot Number21KBO008
Distribution
Distribution scope not specified by the agency.
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