Z-0521-2023 Class II Ongoing

Recalled by Stradis Medical, LLC dba Stradis Healthcare — Peachtree Corners, GA

Recall Details

Product Type
Devices
Report Date
December 21, 2022
Initiation Date
November 2, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25 units

Product Description

HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890

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 Pattern

US nationwide distribution, and Canada.

Code Information

UDI/DI (case) H65857028901, UDI/DI (kit)M75257028900, Serial/Lot Numbers: 22262492001