The Recall Desk
HighFDA (Devices)·Z-1549-2022·Announced 2022-08-24

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.
Hazard
  • allergen-latex
  • mislabeling

Distribution

Distributed nationwide across the United States.