Z-0409-2009

PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF...

Name: Z-0409-2009 PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF...
Creator: Covidien
Published: 2008-09-19
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-09-19 / Terminated

FDA source

Covidien began a recall of 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... on 2008-09-19. The reason FDA records is "Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0409-2009
Status: Terminated
Initiated: 2008-09-19
Posted: 2008-12-04
Terminated: 2008-12-04
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: NYU Catheter, Hemodialysis, Implanted, Coated
Reason for recall: Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
FDA root cause: Mixed-up of materials/components
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.
Quantity in commerce: 5 units
Distribution: Nationwide distribution including states of OH, WI, LA, TX, UT, CA, OR, and WA.
Product codes and lots: Product code/REF Number 8888128461; Lot No. 809405

Product code NYU

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)