PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: August 24, 2022 Initiated: June 29, 2022 #Z-1550-2022

Product Description

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

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
2,512 cases (75,360 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 Statlock CS/30 Ref: DC5040LF. Recalled by Trinity Sterile, Inc.. Units affected: 2,512 cases (75,360 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-1550-2022.