Medline Convenience Kits with Defective Plastic Syringes Recalled Globally
Medline recalls convenience kits with defective plastic syringes due to leaks, breakage, and quality issues identified in an FDA Safety Alert. The 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 a Class II recall with no reported illnesses or injuries. The hazard is potential—leaks and breakage that may pose patient risk—but actual harm has not been reported, fitting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medline Industries is recalling multiple medical convenience kits containing plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. The syringes in these kits have been identified with leaks, breakage, and other quality issues that may pose a risk to patient health.
These convenience kits are used in various medical and surgical procedures and have been distributed worldwide. Healthcare facilities and surgical centers that received affected kits should verify their inventory against the provided lot numbers and product names.
Facilities with identified affected kits should stop using them immediately and contact Medline or the FDA for instructions on replacement or proper handling of the recalled products.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS780161K ; 3) HEAD & NECK CDS , Pack Number CDS780161L ; 4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ; 5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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)
- AM310B
- Lot Number 20BBX607
- Lot Number 20FBO876
- Lot Number 20HBG464
- Lot Number 20HBT869
- Lot Number 20JBW307
- Lot Number 20XBG776
- CDS780161K
- Lot Number 19ABJ175
- Lot Number 19CBC247
- Lot Number 19DBJ688
- CDS780161L
- Lot Number 21FBM662
- Lot Number 21JBO079
- Lot Number 21KBU620
- Lot Number 22DBN197
- Lot Number 22EBE676
- Lot Number 22GBA238
- Lot Number 19FBZ495
- Lot Number 22HBH827
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 81 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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