Reported Oct 26, 2022 · Terminated
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Intersurgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intersurgical Inc · 6757 Kinne St · East Syracuse, NY · 13057-1215
Is this the product you have?
- Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg
- Model Number8003000
- Lot codes and dates
- UDI-DISingle unit5030267073511
- UDI-DICase05030267046959
- Lot code32204071
- Amount recalled
- 340 pieces
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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