Home / Recalls / Stradis Medical, LLC dba Stradis Healthcare / Z-0129-2022

Z-0129-2022 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
October 27, 2021
Initiation Date
September 10, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1639 kits

Product Description

Endometrial Biopsy Kit

Reason for Recall

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Distribution Pattern

Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.

Code Information

Part Number: 936K

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)