Medline Medical Convenience Kits with Plastic Syringes Recalled for Quality Defects
Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects that may pose patient health risks following an FDA Safety Alert.
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 potential to cause patient harm through leaking and breaking syringes used in medical procedures. No illnesses or injuries have been reported in the source material, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP (Northfield) is recalling multiple models of medical convenience kits that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The plastic syringes in these kits have exhibited leaks, breakage, and other quality defects that may pose a risk to patient health and safety during medical procedures.
The recalled products are used in healthcare settings and have been distributed worldwide to medical facilities. The recall includes numerous kit variants designed for different medical procedures, with affected lot numbers identified by Medline Industries.
The recalled product
- Product
- Medline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ; 2) ANES CIRC 90 EXP PEDS 2BV-LF, Pack Number 81842 ; 3) AIRWAY EXAM KIT, Pack Number DYKE1796 ; 4) INTUBATION KIT , Pack Number DYKSCRIPPSIN4; 5) INTUBATION KIT , Pack Number D
- 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)
- 35772
- Lot Number 19GBK969
- 81842
- Lot Number 20JBS956
- DYKE1796
- Lot Number 21GBR139
- Lot Number 22HBX360
- Lot Number 22JBR572
- DYKSCRIPPSIN4
- Lot Number 19DAA326
- Lot Number 19EAA345
- Lot Number 19HAB271
- Lot Number 19LAA719
- Lot Number 20AAA102
- Lot Number 20BAA611
- Lot Number 20DAA064
- DYNDA1598C
- Lot Number 23KMF159
- Lot Number 24AMG428
- DYNDA1598CH
Distribution
Distribution scope not specified by the agency.
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