FDA Medical Device Recalls (openFDA)
Greiner VACUETTE North America: Vacuette, Safety Blood Collection Set with Luer Adapter
- Recall number
- Z-0797-03
- Recalling firm
- Greiner VACUETTE North America
- Product
- Vacuette, Safety Blood Collection Set with Luer Adapter
- Status
- Terminated
- Initiated
- 2003-03-10
- Posted
- 2003-05-09
- Terminated
- 2003-08-07
- Reason
- The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.
- Root cause
- Other
- Action
- Consignees were notified via certified letter on/about 3/6/2003 and were advised to stop distributing the product immediately and to discard any remaining product in stock.
- Quantity
- 139000 units
- Distribution
- Product was distributed to medical facilities Nationwide.
- Lot, serial or model codes
- Item no. 450096, Lot #''s 02I09C, 02I11C and 02I20C
- 510(k) numbers
- ["K011786"]
- PMA numbers
- not on file
- Product code
- JKA
- 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