FDA recall Z-1548-2022

Trinity Sterile, Inc. · Class II · device

Product

Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708

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-1548-2022