Z-2235-2016 Class II Terminated
FDA device recall Z-2235-2016 was initiated by WalkMed Infusion, LLC on June 14, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated December 1, 2016). Affected quantity: 1147 cases.
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2016
- Initiation Date
- June 14, 2016
- Termination Date
- December 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1147 cases
Product Description
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.
Reason for Recall
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.
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.
Code Information
Product Number: 020-300828. Lot Number: 1406166, 1406167, 1406168, 1406169, 1407507, 1408134