Dressing Change Kit Recalled for Latex Mislabeling Risk
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.
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 recall involves allergen mislabeling on a common allergen (latex) in a medical device component. No illnesses or injuries have been reported. The mislabeling poses a direct risk to patients with known latex allergies, meeting the criterion for High severity.
Plain-English summary
Trinity Sterile, Inc. is recalling the Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 (Ref: DC5090LF) due to mislabeling regarding latex content.
The packaging for the component 94-7002 Non-Adherent Dressing within the kit contains natural rubber latex. However, the kits are labeled as latex-free, creating a discrepancy between the label and actual contents.
The recall affects 4,169 cases (125,070 individual kits) distributed nationwide in Florida and Pennsylvania. The affected lot numbers are 600000, 600001, 600002, 600003, 600004, 600005, 600008, 600009, 600010, 600011, 600012, 600013, 600014, 600015, 600017, 600018, and 600019.
Patients with latex allergies who use these kits face potential allergic reactions upon exposure to the dressing component. Patients who have purchased affected kits should stop using them immediately and consult their healthcare provider if they have concerns about exposure.
The recalled product
- Product
- Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
- 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.
See all 4 products in this recall →Related recalls
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