Recall Z-0899-03 ยท GKP Instrument, Coagulation, Automated
Diagnostica Stago, Inc.
STA-Compact Hemostasis System with Cap piercing capability.
| Date | May 29, 2003 (initiated Mar 5, 2003) |
| Status | Terminated |
| Reason | With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury. |
| 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 | 79 |
| Distribution | The product was shipped to 47 hospitals throughout the nation. Other units were shipped to the firm sales representatives. |
| FDA record | Open on fda.gov |