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

BD Direct Draw Adapters, Catalog Number 364896.

FDA Recall Z-1463-06 · Posted 2006-09-09

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeKSR
Date Initiated2006-06-21
Date Terminated2007-06-07
Product Quantity234,450 units

Reason for Recall

Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.

Firm Action

BD sent out recall notifications on 6/21/2006 to distributors and their direct account customers.

Root Cause

Other

Distribution Pattern

World wide-Products are distributed nationwide to distributors and direct accounts. The products are also distributed internationally to the following locations: Japan, Australia, Canada, Hong Kong, New Zealand. For European distribution, the products are shipped to Temse located in Belgium who handles the recall. Temse has been identified as recalling only the following products and lots: Catalog Number 364896 (Direct Draw Adapter), lots 5311376, 5312193, 5312201. Catalog Number 367300 (Luer Adapter), lots 5307894, 5307896, 5307900. Government accounts include the VAMC in Erie, PA;

Official Source

View FDA Recall →

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

↑