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

Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch

FDA Recall Z-0027-05 · Posted 2005-03-23

Recalling FirmBioteque America Inc
Recall StatusTerminated
Date Initiated2005-02-24
Date Terminated2005-06-14
Product Quantity115 units

Reason for Recall

product is marketed without a 510(k)

Firm Action

The recalling firm telephoned the distributors and sales representatives on 2/23/05 informing them of the problem and the need to return the product. As a follow up to the telephone call, a recall letter dated 2/24/05 was issued to the distributors.

Root Cause

Other

Distribution Pattern

The products were shipped to distributors in OH and MI. The product was also provided to sales representatives.

Official Source

View FDA Recall →

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

↑