BlueFIRE Inflation Device Recalled for Sterile Barrier Defect Risk
BlueFIRE Inflation Devices may have a small hole in the sterile barrier, potentially exposing patients to pathogens that could cause infection. Contact your healthcare provider if you received this device.
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: This is an FDA Class II recall involving a sterile barrier defect that creates potential exposure to pathogens and pyrogens, which could cause infection. However, no illnesses or injuries have been reported as of the recall announcement, making this a high-risk product with theoretical rather than realized harm.
Plain-English summary
Merit Medical Systems has recalled the BlueFIRE Inflation Device, Model REF: IN10140. The affected devices may contain a small hole in the sterile barrier, which could expose patients to pathogens and pyrogens and potentially lead to infection.
The recall affects devices distributed worldwide, including throughout the United States and internationally to France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, and Japan. A total of 5 units are affected, identified by UDI-DI 00884450363607 and Lot H2934827 (Expiration: 4/30/2027).
No cases of infection or patient harm have been reported as of this recall announcement. Patients who have received this device should contact their healthcare provider immediately to discuss whether they have been affected and to determine appropriate next steps, which may include device replacement or clinical follow-up.
The recalled product
- Product
- BlueFIRE Inflation Device, REF: IN10140
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device
- Hazard
- sterile-barrier-defect
- pathogen-exposure
- infection-risk
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)
- REF/UDI-DI/Lot(Expiration): IN10140/00884450363607/H2934827(4/30/2027)
Distribution
Distributed nationwide across the United States.
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