medical MODERATE Updated 2022-10-26

Intersurgical Inc recalls Intersurgical Solus Standard, laryngeal mask airway, size 3,

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Affected States: OH, TN, TX
Lot/Code Info: UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall