T100-120F with 1.2 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.
Recall
- Recall Number
- Z-2233-2016
- Event Number
- 74437
- Firm
- WalkMed Infusion, LLC
- FEI Number
- 3000204189
- Product Code
- FPA
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 14, 2016
- Terminated
- December 1, 2016
- Address
- 6555 S Kenton St, Ste 304, Englewood, CO, 80111-6838
Description
T100-120F with 1.2 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.
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.
Terumo sent a notification letter dated June 8, 2016 to customers. The letter identified the affected product, problem and action to be taken. Customers were instructed to 1. Review this notice and ensure that all users receive notice of this issue. 2. Return the attached Customer Response Form acknowledging receipt of this notice. 3. Source a replacement for the Interchlor sanitizer. See information above or call Terumo CVS Technical Support for assistance. 4. Terumo CVS will provide users with updated user instructions regarding the 10% Sodium Hypochlorite sanitization solution. Instructions will be provided under separate cover, when available. For questions contact your Terumo representative or contact Terumo CVS Technical Support at 800.441.3220, extension 6932.
US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.
295 cases