FDA (Devices) recall action 79713
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.
Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.
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.
Cook Inc. is recalling 2,267 Cook Vacuum Pumps (K-MAR-5200-US) worldwide due to defective crimp connectors that may cause device failure, electric shock, or burns.
Cook Inc. is recalling 132 Cook Vacuum Pumps (K-MAR-5200-US) worldwide due to defective crimp connectors that may cause device failure, electric shock, or burns.