Device product
T100-000VF, IV Set with Lower Y Site and Free Flow 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-2230-2016
Product summary
- Event
- Event 74437
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1857 cases
- Official record key
device-enforcement:Z-2230-2016
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: 020-300643. Lot Number: 1406089, 1407017, 1407018, 1407019, 1407506, 1408132, 1412071D, 1412114D, 1501110D, 1503055D, 1506066D, 1508007D
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