Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2220-2016 — The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.

U.S. FDA — Device Enforcement · United States · 2016-06-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2220-2016
Date of alert: 2016-06-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: WalkMed Infusion, LLC
Product category: device
Product type: Devices

Reported risk: WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2220-2016 — The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.

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