Device product
T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & 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-2235-2016
Product summary
- Event
- Event 74437
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1147 cases
- Official record key
device-enforcement:Z-2235-2016
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: 020-300828. Lot Number: 1406166, 1406167, 1406168, 1406169, 1407507, 1408134
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