FDA recall Z-1550-2022

Trinity Sterile, Inc. · Class II · device

Product

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

Distribution

US Nationwide distribution in the states of FL, PA.

Key facts

Status: Terminated
Initiation date: 2022-06-29
Report date: 2022-08-24
Termination date: 2024-05-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1550-2022