Stradis Healthcare: Medical Device Recall in 2023 - (Recall #: Z-0938-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.

Product Classification:

Class II

Date Initiated: December 15, 2022

Date Posted: January 18, 2023

Recall Number: Z-0938-2023

Event ID: 91350

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.

Status: Ongoing

Product Quantity: 112,675 units

Code Information:

Assembly Number HCT3548-2, UDI-DI: M752HCT354821, Lot Numbers: 222770947, 221809694, 221938965, 221748547, 221578546, 221808445, 221386002, 222859338, 222940522, 221938972

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated