Device 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.
Z-2870-2016
Product summary
- Event
- Event 74952
- Status
- Terminated
- Classification
- Class II
- Quantity
- 282 cartons (1000 units per carton)
- Official record key
device-enforcement:Z-2870-2016
Official wording
Reason: The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.
Code information: Model Number: MED 5223, Lot Number: 201505 l0
Distribution pattern: FL
Derived failure modes
-
Unknown
The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.