FDA Medical Device Recalls (openFDA)
WalkMed Infusion, LLC: 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.
- Recall number
- Z-2235-2016
- Recalling firm
- WalkMed Infusion, LLC
- Product
- 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.
- Status
- Terminated
- Initiated
- 2016-06-14
- Posted
- not on file
- Terminated
- 2016-12-01
- 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. 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.
- Quantity
- 1147 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.
- Lot, serial or model codes
- Product Number: 020-300828. Lot Number: 1406166, 1406167, 1406168, 1406169, 1407507, 1408134
- 510(k) numbers
- ["K073444"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3000204189
- Firm city
- Englewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28