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Recall Observatory FDA recall evidence

Device product

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

Z-0931-2023

December 15, 2022

Class II

Product summary

Firm
Stradis Healthcare
Event
Event 91350
Status
Ongoing
Classification
Class II
Quantity
920 units
Official record key
device-enforcement:Z-0931-2023

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

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