Recall Z-2231-2016 ยท FPA Set, Administration, Intravascular
WalkMed Infusion, LLC
T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, 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.
| Date | Jun 14, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. Instru |
| Quantity | 2198 cases |
| Distribution | US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073444 | TRITON MEIDCAL TMED IV-SET Triton Medical, LLC, Aug 18, 2008 |