FDA (Devices) recall action 90625
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.
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
The agency’s own wording, quoted from the enforcement report.
Trinity Sterile's IV catheter dressing trays are mislabeled as latex-free despite containing natural rubber latex in component 94-7002, risking allergic reactions in latex-sensitive users.
Trinity Sterile is recalling Wolf Pak Premium Dressing Change Kits labeled as latex-free. The Non-Adherent Dressing component contains natural rubber latex, creating risk for patients with latex allergies.
Trinity Sterile's Wolf Pak Premium Dressing Change Kit is mislabeled as latex-free but contains natural rubber latex in component 94-7002. This poses a risk to people with latex allergies.
Wolf-Pak Premium Dressing Kits labeled latex-free are being recalled because a component contains natural rubber latex, posing a risk to people with latex allergies.