Medline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
Medline Industries is recalling medical convenience kits containing plastic syringes with leaks, breakage, and other quality issues that may pose a risk to patient health.
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 recall of medical syringes with identified defects (leaks, breakage, quality issues) that may pose risk to patient health. No illnesses or injuries have been reported, qualifying this as high severity for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling medical convenience kits that contain plastic syringes. The kits are distributed worldwide and include 68 different product types, each identified by specific pack numbers and lot numbers.
The plastic syringes in these kits have been identified as defective following an FDA Safety Alert issued on March 19, 2024. Issues include leaks, breakage, and other quality defects that may pose a risk to patient health.
Healthcare facilities and medical providers who have received these kits should stop using the affected lot numbers and contact Medline Industries for guidance. Consumers and patients with questions about affected products should refer to the official FDA recall notice.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 5) ARTHROGRAM TRAY…
- 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)
- DYNDA2063
- Lot Number 2021111250
- DYNDA2080
- Lot Number 2019052290
- DYNDA2495
- Lot Number 2021040550
- DYNDA2497
- Lot Number 2022042650
- DYNDH1113
- Lot Number 2020022450
- DYNDH1134
- Lot Number 2021022250
- DYNDH1137C
- Lot Number 2021081990
- DYNDH1257
- Lot Number 2019120650
- Lot Number 2020060550
- Lot Number 2021041550
- DYNDH1270
- Lot Number 2019040490
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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