Merit Medical Systems Recalls Custom Angiography Kits with Sealing Defects
Merit Medical Systems is recalling 90 custom angiography 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 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 90 units of the Custom Inflation Kit (Product Code: K05T-02533, Lot # T1883210) intended for angiography and angioplasty procedures. The recall is due to a defect where the header bags on these kits may not be fully sealed, which compromises the sterile barrier of the medical devices.
The affected kits were distributed in Kentucky, Rhode Island, and Maryland. The kits contain various surgical items, including drapes, towels, needles, syringes, and an inflation device. The compromised sterile barrier could result in exposure to non-sterile devices, which may lead to an infection requiring medical treatment.
Healthcare facilities and consumers who have these specific kits should stop using them immediately and contact Merit Medical Systems for instructions on how to return the product.
The recalled product
- Product
- Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 90
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)00884450255803 Lot # T1883210
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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