STA-Compact Hemostasis System with Cap piercing capability.
- Company
- Diagnostica Stago, Inc.
- Recall Initiated
- March 5, 2003
- Posted
- May 29, 2003
- Terminated
- September 9, 2003
- Recall Number
- Z-0899-03
- Quantity
- 79
- Firm Location
- Parsippany, NJ
Reason for Recall
With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.
Distribution
The product was shipped to 47 hospitals throughout the nation. Other units were shipped to the firm sales representatives.
Lot / Code Info
All distributed units with cap piecing option.
Root Cause
Other
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
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