Merit Medical Systems Recalls Custom Embolization Kits Due to Sterility Concerns
Merit Medical Systems is recalling 42 custom embolization kits because header bags may not be fully sealed, potentially compromising the sterile barrier and leading to infection.
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: The recall involves a risk-of-harm product (compromised sterile barrier leading to potential infection) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Merit Medical Systems, Inc. is recalling 42 units of the Custom Procedure Kit, Embolization Kit Sterile EO (Product Code: K12T-02871, Revision A). These kits are used for angiography and angioplasty procedures and contain various surgical instruments and supplies, including drapes, needles, syringes, and scalpel.
The recall was initiated because the header bags on these kits may not be fully sealed. This defect could result in a compromised sterile barrier, exposing patients to non-sterile devices. Such exposure may lead to an infection requiring medical treatment.
The affected kits were distributed in Kentucky, Rhode Island, and Maryland. The specific lot number is T1888031. Healthcare facilities and consumers should check their inventory for this product code and lot number. If found, the kits should not be used and should be returned to Merit Medical Systems or the point of purchase.
The recalled product
- Product
- Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL)…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 42
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)
- (01)00884450339121 Lot # T1888031
Distribution
Part of a larger recall action
This product is one of 3 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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