Home / Recalls / Stradis Healthcare / Z-0931-2023

Z-0931-2023 Class II Ongoing

Recalled by Stradis Healthcare — Waukegan, IL

Recall Details

Product Type
Devices
Report Date
January 18, 2023
Initiation Date
December 15, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
920 units

Product Description

Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile

Reason for Recall

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Distribution Pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Code Information

a. Assembly Number 33066, UDI-DI: M752330661, Lot Numbers: 222782334, 222519530, 222438660; b. Assembly Number 33068, UDI-DI: M752330681, Lot Numbers: 222145412, 220551558, 222508466

Other recalls by Stradis Healthcare

  • Z-0943-2023 Class II — McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McC (December 15, 2022)
  • Z-0946-2023 Class II — Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, (December 15, 2022)
  • Z-0940-2023 Class II — HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technol (December 15, 2022)
  • Z-0939-2023 Class II — HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health (December 15, 2022)
  • Z-0933-2023 Class II — Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein. (December 15, 2022)
  • Z-0948-2023 Class II — Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital (December 15, 2022)
  • Z-0941-2023 Class II — HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Tech (December 15, 2022)
  • Z-0945-2023 Class II — Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags pe (December 15, 2022)
  • Z-0936-2023 Class II — HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER (December 15, 2022)
  • Z-0947-2023 Class II — Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Med (December 15, 2022)