Device product
Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.
Z-1003-2017
Product summary
- Event
- Event 75810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5520 units
- Official record key
device-enforcement:Z-1003-2017
Official wording
Reason: Product malfunction: Needle does not retract.
Code information: Lot 0610525, 2017-10-18
Distribution pattern: US Distribution to the states of : MD, TX, and WI. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
Product malfunction: Needle does not retract.