Summit Medical Nasal Septal Button Recall: Unsealed Sterile Pouches
Summit Medical is recalling 30 Nasal Septal Buttons due to unsealed sterile pouches that compromise product sterility. Patients face potential infection risk from non-sterile device exposure.
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 Class II medical device recall presents a risk-of-harm product defect (unsealed sterile pouches) that compromises device sterility and creates infection risk for patients. No illnesses or injuries have been reported, meeting the criteria for a High severity rating.
Plain-English summary
Summit Medical, LLC is recalling approximately 30 Nasal Septal Buttons, Model SP-78105, Medium size (5cm), due to a manufacturing defect: the sterile product pouches were not sealed. When sterile pouches are not sealed, the product's sterility cannot be assured.
The nasal septal button is designed for use in nasal procedures. Non-sterile devices present a potential infection risk to patients.
The affected devices were distributed in the United States to Colorado, Florida, Georgia, Louisiana, Massachusetts, and Maine, and internationally to Canada. The recalled lot is Lot #219349, with expiration date November 1, 2027.
Patients and healthcare providers should contact Summit Medical, LLC regarding the proper handling of these devices.
The recalled product
- Product
- Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
- Manufacturer
- Summit Medical, LLC
- Hazard
- sterile-failure
- 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 (3)
- Lot #219349
- Exp. 2027-11-01
- UDI (01)00385640065214(17)271101(10)219340
Distribution
Distributed in 6 states:
- CO
- FL
- GA
- LA
- MA
- ME
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