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Recall Observatory FDA recall evidence

Device product

HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.

Z-0939-2023

December 15, 2022

Class II

Product summary

Firm
Stradis Healthcare
Event
Event 91350
Status
Ongoing
Classification
Class II
Quantity
76,260 units
Official record key
device-enforcement:Z-0939-2023

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 HCT3916-1, UDI-DI: M752HCT391611, Lot Numbers: 222491279, 220113056, 222782510, 221306003, 220051819, 222149971, 222210292, 221245035, 221458554

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