FDA Device

STA-Compact Hemostasis System with Cap piercing capability.

Hazard

With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.

What You Should Do

Remedy

The firm sent out letters on March 5, 2003 to their customers alerting them to the problem and providing further guidance on how to prevent the problem. The firm will be sending out to the customers a protective device to attach to the needle assembly as soon as possible

Products

STA-Compact Hemostasis System with Cap piercing capability.
Brand
Diagnostica Stago, Inc.
UPC
All distributed units with cap piecing option.

Units Affected

79