Nasal Sinus Pack Recalled Due to Sterilization Verification Failure
American Contract Systems is recalling Nasal Sinus Pack units due to manufacturing control failures that prevent confirmation of sterilization. Affected units were distributed to multiple states.
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: Manufacturing control failure prevented confirmation of sterilization assurance on a medical device used internally. No illnesses or injuries reported, but sterilization failure of such a device poses theoretical risk of infection.
Plain-English summary
American Contract Systems, Inc. is recalling the Nasal Sinus Pack, Model MTSN26B (Lot 2405093, expiration 05/09/2025). The product is a medical convenience kit.
The recall was initiated after the manufacturer identified that a chart recorder in one of its controlled environment areas was inoperable, resulting in humidity readings that were out of specification. Because of this manufacturing control failure, American Contract Systems is unable to confirm that sterilization assurance requirements were met for affected units.
American Contract Systems has identified approximately 57 affected units distributed to Missouri, Minnesota, Massachusetts, Ohio, and Nebraska.
Consumers and medical professionals who have the recalled product should stop using it and contact American Contract Systems for return or replacement instructions. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Nasal Sinus Pack, MTSN26B; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- sterilization-failure
- manufacturing-defect
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 (3)
- UDI-DI: 00191072200242
- Lot: 2405093
- Exp: 05/09/2025
Distribution
Distributed nationwide across the United States.
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