Recall Z-2190-2008

Cook Vascular Inc. · initiated April 24, 2008

Terminated

Product

Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter

Codes / lots: Catalog number IP-S5118-N. Lot number N73127

Reason for recall

Mislabeled - wrong size catheter was packaged in the box

FDA-determined cause: Packaging process control

Action taken

The recalling firm issued an Urgent Product Recall letter dated 4/30/08 to inform their customers of the problem and the need to return the product. The letter also instructed the customers to notify sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance.

Details

Recall number
Z-2190-2008
Initiated
April 24, 2008
Posted by FDA
September 17, 2008
Terminated
September 18, 2008
Product code
LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular
Quantity
21 units
Distribution
The products were shipped to distributors in Japan and Brazil.
Recalling firm
Cook Vascular Inc., Vandergrift, PA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2191-2008 Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm cathetermislabeled - wrong size catheter was packaged in the box 04/24/2008Terminated