Stradis Healthcare: Medical Device Recall in 2023 - (Recall #: Z-0937-2023)

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 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.

Product Classification:

Class II

Date Initiated: December 15, 2022

Date Posted: January 18, 2023

Recall Number: Z-0937-2023

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: 2,779 units

Code Information:

Assembly Number HCT2050, UDI-DI: M752HCT20502, Lot Number: 220130152, 221677841

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