Merit Medical Systems Recalls Custom Procedure Kits Due to Latex Labeling Error
Merit Medical Systems is recalling 88 Custom Procedure Kits because they were incorrectly labeled as latex-free.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard is a labeling error regarding latex content, which is a significant risk for allergic individuals but does not involve a structural defect or reported fatalities.
Plain-English summary
Merit Medical Systems, Inc. is recalling 88 units of the Custom Procedure Kit, REF/Product Code K12T-03688. The recall was initiated due to a labeling error where the kits were incorrectly identified as latex-free.
The affected products are single-use, prescription-only, sterile kits. The specific lots involved are #T1401193 and #T1419935 under Catalog #K12T-03688H. These kits were distributed in the United States to Virginia and Illinois.
Patients and healthcare providers should check their inventory for these specific lot numbers. If the product is found, it should be returned to Merit Medical Systems for credit or replacement. Individuals with latex allergies should consult their healthcare provider if they have used these kits.
The recalled product
- Product
- Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 88
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)
- Catalog #K12T-03688H - Lot #T1401193 and #T1419935
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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