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

Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number: 120021

FDA Recall Z-1148-06 · Posted 2006-06-17

Recalling FirmUnited States Surgical
Recall StatusTerminated
Product CodeFOZ
Date Initiated2006-05-22
Date Terminated2007-12-12
Product Quantity63 UNITS

Reason for Recall

The 9F device may contain a 10 F sheath instead of the 9F

Firm Action

United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers.

Root Cause

Other

Distribution Pattern

Nationwide and International Australia, Brazil, Panama City, Singapore, Chile, France, Germany, Israel, Argentina, Quebec

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.

↑