Merit Medical Systems Recalls Non-Sterile Custom Syringe Kits
Merit Medical Systems is recalling 15 syringe kits labeled as sterile but not sterilized. The products were distributed in the US, Thailand, and Hong Kong.
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 recall is classified as FDA Class II. The hazard involves a medical device labeled as sterile but not sterilized, which poses a significant risk of infection or serious injury if used in a clinical setting, meeting the criteria for a Severe rating.
Plain-English summary
Merit Medical Systems, Inc. is recalling 15 units of the Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO. The recall is due to the products being labeled as sterile but not actually sterilized.
The affected lot number is H574228. The products were distributed nationwide in the United States (specifically in Wisconsin) and internationally in Thailand and Hong Kong.
Consumers and healthcare facilities should stop using these products immediately and contact Merit Medical Systems for instructions on return or replacement.
The recalled product
- Product
- Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Syringe Kits
- Hazard
- Affected units
- 15
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 (1)
- Lot Number H574228
Distribution
Part of a larger recall action
This product is one of 2 recalled by Merit Medical Systems, Inc. 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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