FDA Enforcement
Class II
Terminated
T095-120 IV Set with 1.2 Micron Filter. 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.
Recall: Z-2228-2016
·
Reported July 27, 2016
Enforcement
- Recall Number
- Z-2228-2016
- Event ID
- 74437
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- WalkMed Infusion, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- July 27, 2016
- Initiation Date
- June 14, 2016
- Classification Date
- July 18, 2016
- Termination Date
- December 1, 2016
- Address
- 6555 S Kenton St Ste 304, N/A, Englewood, CO, 80111-6838, United States
Description
T095-120 IV Set with 1.2 Micron Filter. 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
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 Info
Product Number: 020-300577. Lot Number: 1407025
Distribution
US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.
Quantity
58 cases