Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF
Check against the official notice below — it lists the full affected range.
Trinity Sterile, Inc. is recalling Wolf-Pak Premium Dressing Kits with GuardVA (reference number DC5030LF) because the kits are mislabeled as latex-free when the packaging for the component 94-7002 Non-Adherent Dressing actually contains natural rubber latex. This poses a potential risk to people with latex allergies. The recall affects 1,513 cases (45,390 individual kits) that were distributed nationwide in Florida and Pennsylvania. The affected kits have lot numbers 600000 through 600008.
The record does not specify a remedy or what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
Reason for recall: Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy Distribution: US Nationwide distribution in the states of FL, PA. Quantity: 1,513 cases (45,390 eaches) Lot/code info: UDI-DI: 10850007185760 Case 00850007185763 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600006 600007 600008
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.