FDA recall Z-0495-2023

Stradis Medical, LLC dba Stradis Healthcare · Class II · device

Product

STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,

Reason for recall

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Distribution

US nationwide distribution, and Canada.

Key facts

Status: Ongoing
Initiation date: 2022-11-02
Report date: 2022-12-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Peachtree Corners, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0495-2023