Recall Z-1171-2023— Summit Medical, LLC
Class II · Ongoing
Class II FDA medical device recall by Summit Medical, LLC, initiated 2023-01-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.. Reason: Sterile product pouches were not sealed..
- Recalling firm
- Summit Medical, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-01-13
- Firm location
- Eagan, MN, United States
Product description
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Reason for recall
Sterile product pouches were not sealed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.