The FDA Enforcement Report for the week of December 19, 2012 lists the ongoing Class II Recall of the Plum A+ single channel infusion pumps with plug-and-play modules from Hospira Inc, Lake Forest, Ill, voluntarily initiated by the firm on October 26, 2012.
The recall concerns the Plum A+ single channel infusion pumps with plug-and-play modules that provide wired Ethernet and wireless local area networking. The Plum A+ infusion system is a dual-line volumetric infusion pump that provides precise delivery of multiple IV therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, med/surg, pediatrics, outpatient clinics, and home care.
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.
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