Skip to content
Recall Observatory FDA recall evidence

Device product

Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.

Z-0933-2023

December 15, 2022

Class II

Product summary

Firm
Stradis Healthcare
Event
Event 91350
Status
Ongoing
Classification
Class II
Quantity
1,040 units
Official record key
device-enforcement:Z-0933-2023

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 570-1130, UDI-DI: H65857011301, Lot Numbers: 222990332, 222692396, 222990334, 221013080, 222529321, 220984273, 222692395, 222368551, 220982614, 222992161.

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