STA-Compact Hemostasis System with Cap piercing capability recallZ-0899-03 · Diagnostica Stago, Inc. · initiated Mar 5, 2003
Terminated All recalls posted in May 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diagnostica Stago, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.
FDA root cause category: Other
What the company is doing
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
Recall details
- Recall number
- Z-0899-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 5, 2003
- Posted by the FDA
- May 29, 2003
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 79
- Product code
- GKP
- FDA submissions
- K961579, K983460
- Distribution
- The product was shipped to 47 hospitals throughout the nation. Other units were shipped to the firm sales representatives.
Product description
STA-Compact Hemostasis System with Cap piercing capability.
Code information (models, lots, serial numbers)
All distributed units with cap piecing option.
Other devices under the same FDA submission
3 devices cleared under K961579, K983460 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- STA-R Evolution® Expert Series 58978Diagnostica Stago · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 death5 reports
- STA R Max® (with cap piercing option) 59010Diagnostica Stago · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES2 reports
- STA R Max® (with cap piercing option) 59027Diagnostica Stago · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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