The Recall Desk
HighFDA (Devices)·Z-1548-2022·Announced 2022-08-24

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.
Hazard
  • allergen-latex
  • mislabeling

Distribution

Distributed nationwide across the United States.