Skip to content
Recall Observatory FDA recall evidence

Device product

HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.

Z-0936-2023

December 15, 2022

Class II

Product summary

Firm
Stradis Healthcare
Event
Event 91350
Status
Ongoing
Classification
Class II
Quantity
644 units
Official record key
device-enforcement:Z-0936-2023

Official wording

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

Code information: Assembly Number HCT10500, UDI-DI: M752HCT105002, Lot Number: 220602531

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    bag having pinhole leaks near the seal, which may result in a breach
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    bag having pinhole leaks near the seal, which may result in a breach in the sterility