Medical Dressing Kit Recalled for Mislabeled Latex Content
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.
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: The recall involves allergen mislabeling on a common allergen (latex). Per the severity rubric, allergen mislabeling on common allergens warrants a High (3) score.
Plain-English summary
Trinity Sterile, Inc. is recalling Wolf-Pak Premium Dressing Kits (model DC5030LF) due to a labeling error. The kits are labeled as latex-free, but component 94-7002 (Non-Adherent Dressing) contains natural rubber latex.
The recall affects approximately 45,390 individual kits distributed nationwide, with cases identified in Florida and Pennsylvania. The affected lot numbers are 600000 through 600008. This mislabeling poses a risk of allergic reaction to individuals with latex sensitivity or latex allergy who may use or handle the product.
Consumers and healthcare facilities in receipt of these kits should stop using them and contact Trinity Sterile, Inc. for replacement kits that are confirmed latex-free. Healthcare providers should verify all affected inventory and follow instructions from their suppliers regarding the recall.
The recalled product
- Product
- Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF
- 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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