Home / Recalls / Stradis Medical, LLC dba Stradis Healthcare / Z-0555-2023

Z-0555-2023 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
16 units

Product Description

STRADIS HEALTHCARE, Breast, Item No.693-276,

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) M7526932761, UDI/DI (kit)M7526932760, Serial/Lot Numbers: 22242490001

Other recalls by Stradis Medical, LLC dba Stradis Healthcare

  • Z-0528-2023 Class II — HENRY SCHEIN, RHINO PACK, Item No.570-3070 (November 2, 2022)
  • Z-0542-2023 Class II — STRADIS HEALTHCARE, Surgery PK, Item No.682-1728, (November 2, 2022)
  • Z-0490-2023 Class II — STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray (November 2, 2022)
  • Z-0522-2023 Class II — HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891 (November 2, 2022)
  • Z-0505-2023 Class II — HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482 (November 2, 2022)
  • Z-0530-2023 Class II — HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089 (November 2, 2022)
  • Z-0549-2023 Class II — www.StradisHealthcare.com, Endovenous Pack, Item No.682-494, (November 2, 2022)
  • Z-0499-2023 Class II — STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001 (November 2, 2022)
  • Z-0513-2023 Class II — HENRY SCHEIN, VEIN TRAY, Item No.570-2738, (November 2, 2022)
  • Z-0511-2023 Class II — HENRY SCHEIN, ENT PACK, Item No.570-2718 (November 2, 2022)