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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMarch 05, 2003
Date PostedMay 29, 2003
Recall Status1 Terminated 3 on September 09, 2003
Recall NumberZ-0899-03
Recall Event ID 25823
510(K)NumberK961579 K983460 
Product Classification Instrument, Coagulation, Automated - Product Code GKP
ProductSTA-Compact Hemostasis System with Cap piercing capability.
Code Information All distributed units with cap piecing option.
FEI Number 2245451
Recalling Firm/
Manufacturer		 Diagnostica Stago, Inc.
5 Century Drive
Parsippany NJ 07054
For Additional Information ContactJames 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 2		Other
ActionThe 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 Commerce79
DistributionThe product was shipped to 47 hospitals throughout the nation. Other units were shipped to the firm sales representatives.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GKP
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