FDA Devices Moderate Class II Ongoing

STRADIS HEALTHCARE, Lipo, Item No.681-254,

Reported: December 21, 2022 Initiated: November 2, 2022 #Z-0536-2023

Product Description

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.

Details

Recalling Firm: Stradis Medical, LLC dba Stradis Healthcare
Units Affected: 6 units
Distribution: US nationwide distribution, and Canada.
Location: Peachtree Corners, GA

Frequently Asked Questions

What product was recalled? ▼

STRADIS HEALTHCARE, Lipo, Item No.681-254,. Recalled by Stradis Medical, LLC dba Stradis Healthcare. Units affected: 6 units.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on December 21, 2022. Severity: Moderate. Recall number: Z-0536-2023.

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