Medline Convenience Kits Recalled Due to Defective Plastic Syringes
Medline is recalling multiple convenience kits containing plastic syringes with leaks, breakage, and quality defects identified by the FDA. These defects 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 device kits without reported illnesses or injuries. The identified hazards—syringe leaks and breakage in clinical use—represent a potential risk of patient harm, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling convenience kits that contain plastic syringes affected by a March 19, 2024 FDA Safety Alert. The affected kits are used in various medical procedures including general endoscopy, gastroenterology, ENT, urology, and vascular interventions.
The plastic syringes in these kits have been identified with leaks, breakage, and other quality issues that may pose a risk to patient health. The affected units are distributed worldwide.
Medical facilities that received the affected convenience kits should immediately stop using units matching the recalled lot numbers. Facilities should verify their inventory against the specific lot numbers provided and contact Medline Industries for return and replacement instructions. Healthcare providers should assess whether any affected syringes may have been used in patient procedures.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B; 3) ENDO KIT, Pack Number DYKE1487C; 4) BRONCH ENDO W/O BEDSIDE KIT , Pack Number DYKE1634 ; 5) ENDO KIT, Pack Number DYKE1696 ; 6)
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leak
- syringe-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)
- CDS984155G
- Lot Number 21GBT672
- Lot Number 21JBH429
- Lot Number 21LBP590
- Lot Number 22CBJ567
- Lot Number 22FBB170
- Lot Number 22GBB172
- Lot Number 22GBW487
- Lot Number 22HBN079
- Lot Number 22IBR934
- Lot Number 19LBO258
- Lot Number 20BBE301
- Lot Number 20EBC706
- Lot Number 20EBS188
- Lot Number 20GBA894
- Lot Number 20IBD347
- Lot Number 20JBK812
- Lot Number 21BBO717
- Lot Number 21EBO578
- DYKE1455B
Distribution
Distribution scope not specified by the agency.
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