Medline pediatric anesthesia circuit kits with defective plastic syringes
Medline procedural kits contain plastic syringes with leaks, breakage, and quality issues that may pose patient health risks. Affected units have been distributed worldwide.
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 an FDA Class II medical device recall affecting high-risk anesthesia equipment. The hazard is potential rather than confirmed (leaks and breakage that 'may pose a risk'), with no reported illnesses or injuries, matching the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling pediatric anesthesia circuit kits (Pack Numbers DYNJAA0327F and DYNJAA0327G) due to defects in the plastic syringes they contain. The recalled syringes are part of an FDA Safety Alert issued March 19, 2024. Nine specific lot numbers are affected by this recall.
The plastic syringes exhibit leaks, breakage, and other quality issues that may pose a risk to patient health. These defects were identified as part of the FDA Safety Alert.
These kits have been distributed worldwide. Healthcare facilities and medical professionals should verify the lot numbers of any kits in their possession against the affected lot list. Facilities with affected inventory should contact Medline Industries for replacement or remediation guidance.
The recalled product
- Product
- Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327G
- 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 (11)
- DYNJAA0327F
- Lot Number 20LBV329
- DYNJAA0327G
- Lot Number 21FBM358
- Lot Number 22CBY412
- Lot Number 22GBZ157
- Lot Number 22JBR268
- Lot Number 23BBL309
- Lot Number 23HBU238
- Lot Number 23KBB605
- Lot Number 24CBJ211
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 27 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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