PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: August 24, 2022 Initiated: June 29, 2022 #Z-1551-2022

Product Description

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

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

Details

Recalling Firm
Trinity Sterile, Inc.
Units Affected
4,169 cases (125,070 eaches)
Distribution
US Nationwide distribution in the states of FL, PA.
Location
Salisbury, MD

Frequently Asked Questions

What product was recalled?
Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF. Recalled by Trinity Sterile, Inc.. Units affected: 4,169 cases (125,070 eaches).
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Devices on August 24, 2022. Severity: Moderate. Recall number: Z-1551-2022.