FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: STA-Compact Hemostasis System with Cap piercing capability.
- Recall number
- Z-0899-03
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- STA-Compact Hemostasis System with Cap piercing capability.
- Status
- Terminated
- Initiated
- 2003-03-05
- Posted
- 2003-05-29
- Terminated
- 2003-09-09
- 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.
- Lot, serial or model codes
- All distributed units with cap piecing option.
- 510(k) numbers
- ["K961579","K983460"]
- PMA numbers
- not on file
- Product code
- GKP
- Firm FEI
- 2245451
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28