Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Summary
The FDA issued a Class II for Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50k by Intersurgical Inc. 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 a.
Details
Source
Device Recall
External ID
Z-0096-2023
Action Date
2022-10-26
Status
Terminated
Category
device
Product Description
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Lot/Code Info: UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071
Quantity Affected: 340 pieces
Reason for Recall
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
Distribution
OH, TN, TX
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-29
Company
East Syracuse, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 184 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Intersurgical Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Intersurgical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intersurgical Inc have FDA actions?
Intersurgical Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0096-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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