Home / Recalls / Stradis Medical, LLC dba Stradis Healthcare / Z-0496-2023

Z-0496-2023 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
12 units

Product Description

STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental

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) M75241213ATCP1, UDI/DI (kit)M75241213ATCP0, Serial/Lot Numbers: 22262491452

Other recalls by Stradis Medical, LLC dba Stradis Healthcare

  • Z-0520-2023 Class II — HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883 (November 2, 2022)
  • Z-0547-2023 Class II — STRADIS HEALTHCARE, Medical Vein, Item No.682-330, (November 2, 2022)
  • Z-0525-2023 Class II — HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930 (November 2, 2022)
  • Z-0539-2023 Class II — STRADIS HEALTHCARE, Ablation Pack, Item No.682-130, (November 2, 2022)
  • Z-0557-2023 Class II — HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549, (November 2, 2022)
  • Z-0492-2023 Class II — Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray (November 2, 2022)
  • Z-0508-2023 Class II — HENRY SCHEIN, Basin Set, Item No.570-1803 (November 2, 2022)
  • Z-0526-2023 Class II — HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946 (November 2, 2022)
  • Z-0523-2023 Class II — HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900, (November 2, 2022)
  • Z-0521-2023 Class II — HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890 (November 2, 2022)