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FDA (Device enforcement)Recalled 2022-06-29closedclass ii

Trinity Sterile, Inc.: Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

Is my product affected?

Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

  • UPC 10850007185722
  • UPC 00850007185725

Check against the official notice below — it lists the full affected range.

What happened

Trinity Sterile, Inc. is recalling Wolf Pak Premium Dressing Change Kits (reference DC5090LF) because the kits are mislabeled as latex-free when a component inside—the 94-7002 Non-Adherent Dressing—actually contains natural rubber latex. This poses a risk to people with latex allergies. The affected kits were distributed nationwide in Florida and Pennsylvania, with 4,169 cases (125,070 individual kits) involved in the recall across lot numbers 600000 through 600019.

The affected kits can be identified by UDI-DI 10850007185722 and Case code 00850007185725. The record does not specify what action affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: 4,169 cases (125,070 eaches) Lot/code info: UDI-DI: 10850007185722 Case 00850007185725 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012 600013 600014 600015 600017 600018 600019

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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