Merit Medical Recalls Pressure Monitoring Kits Due to Sterile Barrier Compromise
Merit Medical Systems is voluntarily recalling 130 MeriTrans Pressure Monitoring Kits because a compromised sterile barrier may affect product sterility.
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 is classified as FDA Class II and involves a compromised sterile barrier, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Merit Medical Systems, Inc. has announced a voluntary field action for 130 units of the MeriTrans Pressure Monitoring Kit (Catalog Number K11-00232G, Lot Number H996490). The recall is being conducted because the sterile barrier for these kits is compromised, which may affect the sterility of the product.
The affected units were distributed nationwide to Virginia, Utah, and North Carolina, as well as to a foreign consignee in Japan. The source text notes that there were no Canadian or VA/government/military consignees.
Consumers and healthcare providers should stop using the affected kits and contact Merit Medical Systems for further instructions or a replacement. This action is classified as a Class II recall by the FDA.
The recalled product
- Product
- Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 130
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: H996490
Distribution
Part of a larger recall action
This product is one of 5 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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