FDAClass IIAugust 24, 2022

Wolf Pak Premium Dressing Change Kit with Statlock recall: Labeling Error

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

Why was Wolf Pak Premium Dressing Change Kit with Statlock recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 10850007185746 Case 00850007185749 Kit Lot Numbers: 600000 600001 600002 600003 600004 600005 600008 600009 600010 600011 600012

Product
Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
Recalling firm
Trinity Sterile, Inc.
Quantity
2,512 cases (75,360 eaches )
Distribution
US Nationwide distribution in the states of FL, PA.
Recall date
August 24, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls