Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Reported: March 8, 2023 Initiated: January 13, 2023 #Z-1171-2023
Product Description
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Reason for Recall
Sterile product pouches were not sealed.
Details
- Recalling Firm
- Summit Medical, LLC
- Units Affected
- 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.
- Location
- Eagan, MN
Frequently Asked Questions
What product was recalled? ▼
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.. Recalled by Summit Medical, LLC. Units affected: 30 devices.
Why was this product recalled? ▼
Sterile product pouches were not sealed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 8, 2023. Severity: Moderate. Recall number: Z-1171-2023.
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