Z-1171-2023 Class II Ongoing

Recalled by Summit Medical, LLC — Eagan, MN

Recall Details

Product Type
Devices
Report Date
March 8, 2023
Initiation Date
January 13, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30 devices

Product Description

Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.

Reason for Recall

Sterile product pouches were not sealed.

Distribution Pattern

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.

Code Information

Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340