Z-0899-03

STA-Compact Hemostasis System with Cap piercing capability

Name: Z-0899-03 STA-Compact Hemostasis System with Cap piercing capability
Creator: Diagnostica Stago, Inc.
Published: 2003-03-05
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2003-03-05 / Terminated

FDA source

Diagnostica Stago, Inc. began a recall of STA-Compact Hemostasis System with Cap piercing capability on 2003-03-05. The reason FDA records is "With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0899-03
Status: Terminated
Initiated: 2003-03-05
Posted: 2003-05-29
Terminated: 2003-09-09
Recalling firm: Diagnostica Stago, Inc.
Product: STA-Compact Hemostasis System with Cap piercing capability.
Product code: GKP Instrument, Coagulation, Automated
Reason for recall: With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.
FDA root 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.
Product codes and lots: All distributed units with cap piecing option.

Product code GKP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)