FDA (Devices) recall action 76476
The FDA (Devices) publishes a recall like this one as 12 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 12 pages.
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
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.
LeMaitre Vascular is recalling Reddick Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.
LeMaitre Vascular is recalling 608 Reddick Cholangiogram Catheters because the latex warning symbol was not printed on the packaging.
LeMaitre Vascular is recalling 247 units of Scoop Tip Cholangiogram Catheters because the latex warning symbol was missing from the packaging.
LeMaitre Vascular is recalling 4,673 units of Scoop Tip Cholangiogram Catheters because the latex warning symbol was not printed on the packaging.
LeMaitre Vascular is recalling 250 units of Reddick Cholangiogram Stiffer Catheters because the latex warning symbol was not printed on the packaging.
LeMaitre Vascular is recalling 46 units of Reddick Scoop Tip Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.
LeMaitre Vascular is recalling Reddick Cholangiogram Catheters because the latex symbol was not printed on the packaging, posing a risk to latex-allergic patients.
LeMaitre Vascular is recalling 2,065 units of Scoop Tip Cholangiogram Catheters because the latex symbol was not printed on the packaging.
LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.
LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Catheters because the latex symbol was not printed on the packaging.
LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Catheters because the latex warning symbol was missing from the packaging.
LeMaitre Vascular is recalling 340 Reddick Cholangiogram Stiffer Catheters because the latex symbol was not printed on the packaging.