Home / Recalls / WalkMed Infusion, LLC / Z-0242-2016

Z-0242-2016 Class II Terminated

Recalled by WalkMed Infusion, LLC — Englewood, CO

Recall Details

Product Type
Devices
Report Date
November 18, 2015
Initiation Date
October 1, 2015
Termination Date
July 12, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4695 units

Product Description

Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.

Reason for Recall

The device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector and the Total Volume Limit is programmed higher than the actual bag volume.

Distribution Pattern

Distributed in the states of AL, CA, CO, DE, FL, GA, IL, MA, MD, MI, MN, MS, NC, NJ, NM, NV, NY, OH, PA, TN, TX, and WA.

Code Information

Model numbers 300000, 400000

Other recalls by WalkMed Infusion, LLC

  • Z-2223-2016 Class II — T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches pe (June 14, 2016)
  • Z-2231-2016 Class II — T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free F (June 14, 2016)
  • Z-2221-2016 Class II — Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per (June 14, 2016)
  • Z-2234-2016 Class II — T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, w (June 14, 2016)
  • Z-2235-2016 Class II — T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Cl (June 14, 2016)
  • Z-2233-2016 Class II — T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 (June 14, 2016)
  • Z-2222-2016 Class II — T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 (June 14, 2016)
  • Z-2220-2016 Class II — The pump (with cushioning foam inserts) is packaged in a single pump box. Four p (June 14, 2016)
  • Z-2229-2016 Class II — T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 50 p (June 14, 2016)
  • Z-2225-2016 Class II — T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Pack (June 14, 2016)