Z-2870-2016Class II

MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only...

Name: Z-2870-2016 MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only...
Creator: Global Healthcare Inc
Published: 2016-08-09
License: https://open.fda.gov/license/

Global Healthcare, Inc. / initiated 2016-08-09 / Terminated

FDA source

Global Healthcare Inc began a recall of MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243... on 2016-08-09. FDA classified it as Class II and gives the reason as "The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2870-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-09
Posted: 2016-09-22
Terminated: 2017-01-23
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.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.
FDA 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 in commerce: 282 cartons (1000 units per carton)
Distribution: FL
Product codes and lots: Model Number: MED 5223, Lot Number: 201505 l0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2870-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2870-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-22

Product code FMI

K000714Class IIVacuflow+safe Blood Collection Set and Vacuflow+safe with Holder Blood Collection SetMed-Pro Technologies, Inc. / cleared 2000-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)