Medical convenience kits with plastic syringes recalled for leaks and breakage
Medline is recalling medical convenience kits with plastic syringes that may leak or break. The FDA issued a safety alert due to quality defects that could harm patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA recall of medical syringes with identified leaks and breakage that may harm patients. No illnesses or injuries have been reported, placing this in the High category for risk-of-harm products without documented injury.
Plain-English summary
Medline Industries is recalling medical convenience kits containing plastic syringes due to identified quality defects. The affected products include filter kits (pack 2008) and anesthesia circuit kits (pack DYNJAA10295A), distributed worldwide.
The syringes in these kits are subject to an FDA Safety Alert issued March 19, 2024. They may have leaks, breakage, and other quality issues that could pose risks to patient health.
Consumers and healthcare facilities should not use the affected kits. Contact Medline Industries or your healthcare provider for guidance. The affected lot numbers are 23ABN325 (filter kits), 22EBI496, and 22CBX850 (anesthesia circuit kits).
The recalled product
- Product
- Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Number DYNJAA10295A
- 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 (5)
- 2008
- Lot Number 23ABN325
- DYNJAA10295A
- Lot Number 22EBI496
- Lot Number 22CBX850
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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