FDA (Devices) recall action 87642
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 firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
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.
Smiths Medical ASD Inc. is recalling 250 units of ACE MDI Spacers with Small Masks because shipping box labels may be incorrect.
Smiths Medical ASD Inc. is recalling 682 Palm Cups because shipping box labels may be incorrect. The devices are intended to mobilize bronchial secretions.