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Recall Observatory FDA recall evidence

Device product

regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

Z-1255-2022

May 03, 2022

Class II

Product summary

Firm
ROi CPS LLC
Event
Event 90199
Status
Terminated
Classification
Class II
Quantity
24 kits
Official record key
device-enforcement:Z-1255-2022

Official wording

Reason: Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.

Code information: UDI (01)10194717102335(17)230531(10)90135, Lot Number 90135, Exp. 2023-05-31

Distribution pattern: FL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.