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

PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888128461, Size 14.5Fr/Ch (4.85mm) x 28cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

FDA Recall Z-0409-2009 · Posted 2008-12-04

Recalling FirmCovidien
Recall StatusTerminated
Product CodeNYU
Date Initiated2008-09-19
Date Terminated2008-12-04
Product Quantity5 units

Reason for Recall

Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.

Firm Action

Starting on 9/19/08, Covidien Sales Representatives visited each of the hospitals that received the catheters, informed the staff that the Venetrac insertion stylets were too short, and placed pink corrective sticker labels on any unused product. Should you require additional information, please contact [email protected] or 508-216-8532.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Nationwide distribution including states of OH, WI, LA, TX, UT, CA, OR, and WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060509PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATINGTyco Healthcare Group · 2006-06-23K05158414.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORYKendall · 2005-10-06

Official Source

View FDA Recall →

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

↑