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

Trinity Sterile, Inc.: Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF

Is my product affected?

Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF

  • UPC 10850007185746
  • UPC 00850007185749

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

What happened

Trinity Sterile, Inc. has recalled Wolf Pak Premium Dressing Change Kits with Statlock CS/30 (Ref: DC5040LF) because the kits are labeled as latex-free, but the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. This poses a risk to consumers with latex allergies. The recall affects 2,512 cases (75,360 individual kits) distributed nationwide in Florida and Pennsylvania.

The affected kits have lot numbers 600000 through 600012 (excluding 600006 and 600007) and can be identified by UDI-DI 10850007185746 and Case code 00850007185749. The source does not specify a remedy for affected consumers.

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: 2,512 cases (75,360 eaches ) Lot/code info: UDI-DI: 10850007185746 Case 00850007185749 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

All FDA (Device enforcement) recalls

Hurt by this product? Start a free Case Check

ProductRisk is not a law firm and does not provide legal services or legal advice. ProductRisk is a free consumer product-safety information service operated by Plaintify, Inc., a technology company. If you ask to be connected with a law firm, any legal services are provided by that firm — not by ProductRisk or Plaintify.

Privacy · Plaintify