STA-Compact Hemostasis System with Cap piercing capability.
FDA device recall Z-0899-03 · posted 2003-05-29 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.
- Action taken
- 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
- Root cause
- Other
- Status
- Terminated
- Product code
- GKP
- Quantity affected
- 79
- Distribution
- The product was shipped to 47 hospitals throughout the nation. Other units were shipped to the firm sales representatives.
- Date initiated
- 2003-03-05
- Date posted
- 2003-05-29
- Date terminated
- 2003-09-09
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAR AUTOMATED MULTI-PARAMETRIC ANALYZER (K983460) | American Bioproducts Co. | 1998-11-12 |
| STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (K961579) | American Bioproducts Co. | 1996-07-10 |