Merit Medical Procedure Kits Recalled for Compromised Sterile Barrier
Merit Medical Systems is voluntarily recalling 178 Fluid Management Sets due to a compromised sterile barrier.
What this means for you
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 compromised sterile barrier on a medical device, which poses a risk of infection or harm. Per the rubric, this is classified as High because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Merit Medical Systems, Inc. has announced a voluntary field action for various Merit Medical Procedure Kits, specifically the Fluid Management Set (Catalog Number K08-MP5159A). The recall is being conducted because the sterile barrier for these devices is compromised.
The affected units are identified by Lot Number H996433. A total of 178 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 Fluid Management Sets and contact Merit Medical Systems for further instructions regarding the field action.
The recalled product
- Product
- Fluid Management Set. Catalog Number K08-MP5159A
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 178
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: H996433
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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