Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.

FDA Recall Z-1329-2021 · Posted None

Recalling FirmOscor, Inc.
Recall StatusTerminated
Product CodeDYB
Date Initiated2021-03-10
Date Terminated2023-08-08
Product Quantity500 devices

Reason for Recall

Potential for open seal on sterile product

Firm Action

The firm notified their sole consignee of the recall by letter on 03/23/2021 as a written follow-up communication held on 03/10/2021 which requested the return of the recalled product.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the state of New York.

Official Source

View FDA Recall →

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

↑