FDA (Devices) recall action 83965
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 metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.
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.
Biomedical Polymers is recalling Manual Diff Droppers because the metal cannula may break or fail to pierce blood specimen tubes.
Biomedical Polymers, Inc. is recalling 108,000 Hemo-Drop Blood Dispensers because the metal cannula may break or fail to pierce the specimen tube.