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

Recall Z-0483-2013 — Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc

U.S. FDA — Device Enforcement · United States · 2012-10-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0483-2013
Date of alert: 2012-10-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Hospira Inc.
Product category: device
Product type: Devices

Reported risk: The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.

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

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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.

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