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Recall Observatory FDA recall evidence

Device product

Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000

Z-0096-2023

August 29, 2022

Class II

Product summary

Firm
Intersurgical Inc
Event
Event 90855
Status
Terminated
Classification
Class II
Quantity
340 pieces
Official record key
device-enforcement:Z-0096-2023

Official wording

Reason: Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient

Code information: UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071

Distribution pattern: OH, TN, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient