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Terminated

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

FDA Recall Z-1171-2023 · Posted 2023-02-24

Recalling FirmSummit Medical, LLC
Recall StatusTerminated
Product CodeLFB
Date Initiated2023-01-13
Date Terminated2026-08-14
Product Quantity30 devices

Reason for Recall

Sterile product pouches were not sealed.

Firm Action

The firm issued "URGENT RECALL NOTICE" Letters dated 1/13/2023 via email. The letter explained the issue and requested the consignee remove the product from inventory and inspect the pouch to verify it is sealed. If the pouch is not sealed, the consignee is to cut the product with scissors and dispose of it. Results of their inspection are to be reported to the recalling firm by email using the enclosed form. A number is listed to arrange for replacement product. The consignee is to indicate on the form that they have read and understand the recall instructions, have checked their stock and disposed of inventory affected, and that they have none of the product left in inventory. If you have any questions, contact Director of Quality Assurance at 651-789-3939 or email: [email protected].

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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