FDA (Devices) recall action 84681
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.
Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
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 Portex LineDraw Arterial Blood Sampling Syringes because the luer connectors may be broken.
Smiths Medical is recalling Portex Pro-Vent Arterial Blood Sampling Kits because some lots may have broken luer connectors.