FDA (Devices) recall action 79817
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 Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
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.
Stryker is recalling three 6381 M-1 Cot Fasteners because their manuals contain incorrect information and missing warnings.
Stryker is recalling 59 M-1 Cot Fasteners distributed to the Netherlands because their operation and maintenance manuals are missing warnings and contain incorrect information.