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

NAMIC Custom Angiographic Kit, Left Heart Kit. - . Model #: H7496019054110. Catalog #601905411. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801.

FDA Recall Z-0303-05 · Posted 2004-12-09

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeFMI
Date Initiated2004-10-21
Date Terminated2005-10-13
Product Quantity24 kits

Reason for Recall

The kits contains defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.

Firm Action

Two customers contacted via phone on 10/21/04 and 10/22/04, followed by letters dated 11/17/2004. Customers instructed to discontinue use and return product. Distributor instructed to notify customers.

Root Cause

Other

Distribution Pattern

2 customers in IL and NV.

Official Source

View FDA Recall →

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

↑