Dressing Change Kit Mislabeled as Latex-Free Contains Natural Rubber Latex
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.
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: This FDA Class II medical device recall involves mislabeling of a common allergen (latex). No illnesses or injuries have been reported. Per the severity rubric, allergen mislabeling on common allergens without reported illness scores 3 (High).
Plain-English summary
Trinity Sterile is recalling the Wolf Pak Premium Dressing Change Kit with Statlock CS/30 (Reference DC5040LF). The kits are mislabeled as latex-free, but component 94-7002 (Non-Adherent Dressing) contains natural rubber latex. This mislabeling poses a risk of allergic reaction in individuals with latex allergies.
Approximately 2,512 cases (75,360 individual kits) have been distributed nationwide in Florida and Pennsylvania. Affected lot numbers include 600000, 600001, 600002, 600003, 600004, 600005, 600008, 600009, 600010, 600011, and 600012. The product can be identified by UDI-DI 10850007185746.
Patients and healthcare providers who have these kits should discontinue use immediately if they or patients have latex allergies. Contact Trinity Sterile or your healthcare provider for information on alternative products. Check the lot number and UDI on your product to determine if it is affected.
The recalled product
- Product
- Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
- Manufacturer
- Trinity Sterile, Inc.
- Hazard
- allergen-latex
- mis-labeling
Distribution
Distributed nationwide across the United States.
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