PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin Coating, REF 8888145070, 14.5 FR/CH (4.85mm) x 28 cm. 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 kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. 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-0411-2009 · Posted 2008-12-04
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Recalling FirmCovidien
Recall StatusTerminated
Product CodeNYU
Date Initiated2008-09-19
Date Terminated2008-12-04
Product Quantity20 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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