Medline Convenience Kits Recalled Due to Plastic Syringe Quality Defects
Medline Industries is recalling medical convenience kits containing plastic syringes with leaks and breakage issues. These defects may pose risks to patient safety during medical procedures.
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 medical devices with identified quality defects (leaks and breakage) in plastic syringes. While no illnesses or injuries have been reported, the defects in medical-use devices create clear risk-of-harm potential during clinical procedures.
Plain-English summary
Medline Industries is recalling multiple convenience kits containing plastic syringes with quality defects. The kits have been distributed worldwide for use in medical procedures.
An FDA Safety Alert issued on March 19, 2024, identified leaks, breakage, and other quality issues in the plastic syringes contained in these kits. These defects may pose a risk to patient health during their use in medical procedures.
The recall affects convenience kit products with worldwide distribution across multiple lot numbers. Healthcare facilities and medical providers should immediately discontinue use of affected kits. Contact Medline Industries or the FDA for guidance on product returns, replacements, or remediation of affected units.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack Num
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Syringes
- Hazard
- syringe-leakage
- syringe-breakage
- device-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)
- ACC010647A
- Lot Number 23CDC070
- Lot Number 23DDA683
- CDS760053K
- Lot Number 22HBP517
- Lot Number 22HBS797
- Lot Number 22LBS190
- Lot Number 23ABC154
- Lot Number 23ABM789
- Lot Number 23EBB486
- Lot Number 23IBP664
- CDS810010J
- Lot Number 19BBU744
- Lot Number 19DBL815
- Lot Number 19FBH859
- Lot Number 19HBO222
- Lot Number 19IBG752
- Lot Number 20BBT732
- Lot Number 20CBY376
- Lot Number 20EBA044
Distribution
Distribution scope not specified by the agency.
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