FDA Medical Device Recalls (openFDA)
Global Healthcare Inc: MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.
- Recall number
- Z-2870-2016
- Recalling firm
- Global Healthcare Inc
- Product
- MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.
- Status
- Terminated
- Initiated
- 2016-08-09
- Posted
- 2016-09-22
- Terminated
- 2017-01-23
- Reason
- The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.
- Root cause
- Under Investigation by firm
- Action
- The distributors were first notified on August 9, 2016 via phone to place product on hold. They were notified of the recall on August 10, 20l6 by email.
- Quantity
- 282 cartons (1000 units per carton)
- Distribution
- FL
- Lot, serial or model codes
- Model Number: MED 5223, Lot Number: 201505 l0
- 510(k) numbers
- ["K000714"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 1000140469
- Firm city
- Alpharetta
- Firm state
- GA
- 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