FDA Medical Device Recalls (openFDA)
Greiner VACUETTE North America: Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria.
- Recall number
- Z-0388-04
- Recalling firm
- Greiner VACUETTE North America
- Product
- Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria.
- Status
- Terminated
- Initiated
- 2003-12-16
- Posted
- 2004-01-29
- Terminated
- 2004-06-07
- Reason
- Product may have a defective connection.
- Root cause
- Other
- Action
- Distributors and end users were notified by certified mail or fax on 12/16/2003.
- Quantity
- 5 cases (5000 pieces)
- Distribution
- The product was shipped to medical facilities in IN, NY and TX.
- Lot, serial or model codes
- Item #450271, Lot #12-8461
- 510(k) numbers
- ["K992145"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3001451379
- Firm city
- Monroe
- Firm state
- NC
- 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