FDA Device

Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.

Hazard

Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm.

What You Should Do

Remedy

Consignees were notified by Dear Healthcare provider letter on 12/10/2007 and were told that a sales rep would remove and replace all affected catheters.

Products

Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.
Brand
Spectranetics Corporation
UPC
Lot Number: 0709158

Units Affected

64