FDA Device

CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable Single Use Only- Rx Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.

Hazard

The reorder number listed on the product label is inaccurate.

What You Should Do

Remedy

Consignees were notified by email/fax on 06/17/2005.

Products

CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable Single Use Only- Rx On
Brand
Wilson-Cook Medical Inc
UPC
Lot Number: R1698831, Labeled Reorder Number CLBS-7-12

Units Affected

1 unit