FDA-Device2022-08-24Class II
Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
Trinity Sterile, Inc.
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
Sold states
US Nationwide distribution in the states of FL, PA.
Affected count
2,512 cases (75,360 eaches )
Manufactured in
201 Kiley Dr, Salisbury, MD, United States
Products
Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1550-2022Don't want to check this manually?
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