FDA Medical Device Recalls (openFDA)
Greiner Bio-One North America, Inc.: VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
- Recall number
- Z-0835-2013
- Recalling firm
- Greiner Bio-One North America, Inc.
- Product
- VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
- Status
- Terminated
- Initiated
- 2013-02-01
- Posted
- 2013-02-15
- Terminated
- 2013-10-29
- Reason
- The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
- Root cause
- Other
- Action
- Greiner Bio-One sent a notification letter dated January 31, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to stop distributing the affected product, complete the attached Product Disposition form and fax to GBO at 800-726-0052 or email to patech@gbo.com. GBO will contact customers for the return of the affected product after receiving the attached Product Disposition form. Customers were requested to provide the names of customers who may have received the product. For questions call 800-515-8112.
- Quantity
- 192,000 pieces (192 cases)
- Distribution
- US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA
- Lot, serial or model codes
- Lot No. 12H27
- 510(k) numbers
- ["K011786"]
- PMA numbers
- not on file
- Product code
- FMI
- 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