FDA (Devices) recall action 64225
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Hospira is recalling 8,214 PCA 3 infusion pumps because the clear plastic door design allows excessive flexing, permitting unauthorized access to medication vials.
Hospira is recalling 38,882 LifeCare PCA infusion systems because the clear plastic door design allows excessive flexing, permitting unauthorized access to medication vials.