Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes
Medline is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. The kits, distributed worldwide, may pose a risk 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: This is an FDA Class II recall of medical devices with quality defects (leaks, breakage) that may pose a risk to patient health. No illnesses or injuries have been reported, placing this in the high-risk category per the rubric, which applies to risk-of-harm products without reported injury.
Plain-English summary
Medline Industries is recalling medical convenience kits containing plastic syringes. The FDA Safety Alert issued on March 19, 2024, identified quality issues in the plastic syringes used in these kits, which are distributed worldwide.
The affected plastic syringes have leaks, breakage, and other quality issues that may pose a risk to patient health. These convenience kits are designed for various medical and surgical procedures.
Healthcare facilities and consumers should not use the recalled convenience kits. The affected products are identified by their specific pack numbers listed in the FDA recall notice. Users should follow proper procedures for handling and disposal of the recalled kits.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ; 5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS76008
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leak
- syringe-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)
- C040100
- Lot Number 19BDB794
- Lot Number 19BDB938
- Lot Number 19CDD009
- Lot Number 19EDC262
- Lot Number 19EDC533
- Lot Number 19JDA569
- Lot Number 19JDA836
- Lot Number 19JDC293
- Lot Number 19LDB582
- Lot Number 20BDA227
- Lot Number 20BDA828
- Lot Number 20BDC639
- Lot Number 20DDA503
- Lot Number 20DDA627
- Lot Number 20HDC033
- Lot Number 21HDA277
- Lot Number 22EDB968
- Lot Number 22HDB951
- CDS760049AD
Distribution
Distribution scope not specified by the agency.
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