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.
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: 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
- Affected units
- 30
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
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