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

ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 7 French Introducer Kit Catalog Number: 120092

FDA Recall Z-1098-05 · Posted 2005-08-06

Recalling FirmUnited States Surgical Corporation
Recall StatusTerminated
Product CodeLJS
Date Initiated2005-06-30
Date Terminated2010-09-14
Product Quantity633 units

Reason for Recall

The tear away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use

Firm Action

United States Surgical notified customers by letter dated June 30, 2005 requesting return of the recalled product.

Root Cause

Other

Distribution Pattern

Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K902135PERCUTANEOUS INTRODUCER KITDevice Labs, Inc. · 1990-08-01

Official Source

View FDA Recall →

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

↑