FDA (Devices) recall action 79579
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
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.
Teleflex Medical Europe Ltd is recalling 200 Baker Jejunostomy Tubes because the packaging lacks a required warning that the product contains natural rubber latex.
Teleflex Medical Europe Ltd is recalling 107,962 latex rebreathing bags because they lack the required warning that the product contains natural rubber latex, which may cause allergic reactions.
Teleflex Medical Europe Ltd is recalling Simplastic Suprapubic Puncture Instruments because the packaging lacks a required warning that the products contain natural rubber latex.
Teleflex Medical Europe Ltd is recalling 6,340 rectal catheters because the packaging lacks a required warning that the product contains natural rubber latex.