Merit Medical Systems Recalls Cardiac Catheterization Kits Due to Sterility Concerns
Merit Medical Systems is recalling 80 cardiac catheterization kits because header bags may not be fully sealed, potentially compromising sterility and increasing infection risk.
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 no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Merit Medical Systems, Inc. is recalling 80 units of the Custom Procedure Kit, Cardiac Cath Pack (Product Code: K12T-10996 Rev. B, Lot # T1907711). These kits are used for angiography and angioplasty procedures and contain various sterile medical supplies, including surgical drapes, gowns, needles, and syringes.
The recall was initiated because the header bags on these kits may not be fully sealed. This defect can compromise the sterile barrier, potentially exposing patients to non-sterile devices. Such exposure may lead to infections that require medical treatment.
The affected kits were distributed in the United States to Kentucky, Rhode Island, and Maryland. Healthcare facilities that have received these kits should stop using them and contact Merit Medical Systems for further instructions.
The recalled product
- Product
- Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. The contents of the kit are surgical drapes, gowns, towels, medicine cups, needles, various bowls, pen and label set (PAL), scalpel…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 80
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)00884450515105 Lot # T1907711
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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