Medline ER Suture Kits Recalled Due to Syringe Quality Issues
Medline is recalling ER Suture Convenience Kits because the included plastic syringes have leaks, breakage, or 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the source text explicitly states that the quality issues 'may pose a risk to patient health,' which aligns with the rubric criteria for a Severe rating involving significant injury risk.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits labeled as KIT,ER SUTURE #1, Pack Number DYNDS1130A. The recall is limited to Lot Number 21JBG946. These kits were distributed worldwide.
The recall is being issued because the medical convenience kits contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified in these syringes, which may pose a risk to patient health.
Healthcare facilities and consumers should stop using the affected kits and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- Medline Convenience kits labeled as: KIT,ER SUTURE #1, Pack Number DYNDS1130A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
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 (2)
- DYNDS1130A
- Lot Number 21JBG946
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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