Medical dressing tray mislabeled as latex-free but contains natural rubber latex
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Allergen mislabeling on latex, a common allergen, without reported illnesses or injuries meets the rubric criterion for High (3). The source contains no adverse event reports, making this a theoretical risk scenario.
Plain-English summary
Trinity Sterile, Inc. has recalled Sklar Instruments IV Cath Dressing Tray (Re-Order Number 96-1708) distributed in Florida and Pennsylvania. The product is mislabeled as latex-free; however, component 94-7002 (Non-Adherent Dressing) contains natural rubber latex. Affected lots are 600001 and 600002.
Individuals with latex allergies face a potential allergic reaction risk if they use this product without knowing about the latex content. The FDA classified this as a Class II medical device recall.
If you have received this product, do not use it if you have a known latex allergy. Contact Trinity Sterile, Inc. or consult a healthcare provider if exposure has occurred.
The recalled product
- Product
- Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
- Manufacturer
- Trinity Sterile, Inc.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Trinity Sterile, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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