Medline Convenience Kits Recalled Due to Leaks and Breakage in Syringes
Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and other quality issues. The defects were identified in an FDA Safety Alert and 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: The recall involves FDA Class II medical device syringes with quality defects (leaks, breakage) that could cause patient harm, but no injuries or illnesses have been reported. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' warranting High severity.
Plain-English summary
Medline Industries, LP is recalling medical convenience kits containing plastic syringes. These kits are distributed worldwide for use in healthcare settings.
The plastic syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. Quality issues including leaks, breakage, and other defects have been identified. These issues may pose a risk to patient health.
Healthcare facilities that have received these kits should immediately stop using affected products. Specific product names, pack numbers, and lot numbers are provided to identify the recalled kits. Facilities should contact Medline Industries for replacement or return instructions.
Any individuals or healthcare providers with questions or concerns about these kits should refer to the FDA recall notice or contact Medline Industries directly.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOPY KIT , Pack Number DYKE1112 ; 4) ENDOSCOPY KIT , Pack Number DYKE1133A; 5) ENDOSCOPY PACK, Pack Number DYKE1264 ; 6) ENDOSCO
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leak
- 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)
- CDS981309O
- Lot Number 19GBS426
- Lot Number 19JBE731
- Lot Number 19LBN327
- Lot Number 20BBE553
- Lot Number 20DBG947
- Lot Number 20GBU396
- CDS984155F
- Lot Number 19GBV870
- Lot Number 19JBX096
- DYKE1112
- Lot Number 23LME611
- DYKE1133A
- Lot Number 22AMA243
- DYKE1264
- Lot Number 22GME430
- Lot Number 22HMA299
- DYKE1389
- Lot Number 19DBL730
- Lot Number 19DBN769
Distribution
Distribution scope not specified by the agency.
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