Summit Medical Nasal Septal Button recall
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Why was Summit Medical Nasal Septal Button recalled?
Sterile product pouches were not sealed.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340
- Product
- Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
- Recalling firm
- Summit Medical, LLC
- Quantity
- 30 devices
- Distribution
- US Distribution was made to CO, FL, GA, LA, MA, and ME. There was no government/military distribution. OUS Foreign distribution was made to Canada.
- Recall date
- March 8, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)