Device product
T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Z-2232-2016
Product summary
- Event
- Event 74437
- Status
- Terminated
- Classification
- Class II
- Quantity
- 383 total cases
- Official record key
device-enforcement:Z-2232-2016
Official wording
Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Code information: Product Number: 020-300649. Lot Number: 1412061D, 1503069D, 1505046D, 1506087D
Distribution pattern: US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.
Derived failure modes
-
Foreign material or chemical contamination
Particulate