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Recall Observatory FDA recall evidence

Device product

Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.

Z-0948-2023

December 15, 2022

Class II

Product summary

Firm
Stradis Healthcare
Event
Event 91350
Status
Ongoing
Classification
Class II
Quantity
200 units
Official record key
device-enforcement:Z-0948-2023

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 VCP16515-1, UDI-DI: M765VCP1651511, Lot Number: 221925083

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