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

Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid or gas such as hysterosalpingography, salpingoplasties, hydrotubation and Rubin''s test. REF TMI1153.

FDA Recall Z-1077-06 · Posted 2006-06-01

Recalling FirmCatheter Research, Inc
Recall StatusTerminated
Product CodeLKF
Date Initiated2006-04-24
Date Terminated2007-12-04
Product Quantity660

Reason for Recall

The uterine stop component was not included with the device.

Firm Action

Distributors were notified by letter dated 4/24/06 and requested to notify their customers to return the product.

Root Cause

Other

Distribution Pattern

Minnesota and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020292UTERINE INJECTORCatheter Research, Inc. · 2002-04-17

Official Source

View FDA Recall →

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

↑