Class 2 Device Recall

• Date Initiated by Firm: March 05, 2003
• Date Posted: May 29, 2003
• Recall Status: Terminated on September 09, 2003
• Recall Number: Z-0899-03
• Recall Event ID: 25823
• 510(K)Number: K961579 K983460
• Product Classification: Instrument, Coagulation, Automated - Product Code GKP
• Product: STA-Compact Hemostasis System with Cap piercing capability.
• Code Information: All distributed units with cap piecing option.
• Recalling Firm/ Manufacturer: Diagnostica Stago, Inc.; 5 Century Drive; Parsippany NJ 07054
• For Additional Information Contact: James A. Barrow; 973-631-1200
• Manufacturer Reason for Recall: With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.
• FDA Determined Cause: Other
• Action: 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
• Quantity in Commerce: 79
• Distribution: The product was shipped to 47 hospitals throughout the nation. Other units were shipped to the firm sales representatives.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GKP and Original Applicant = AMERICAN BIOPRODUCTS CO.