Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412
Summary
The FDA issued a Class II for Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placemen by Ambu Inc.. Reason: Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to lo.
Details
Source
Device Recall
External ID
Z-1420-2022
Action Date
2022-07-27
Status
Ongoing
Category
device
Product Description
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Lot/Code Info: Catalog No: 412351000 UDI-DI: 5707480145706 1 each 5707480145713 5 pc/pack Catalog No. 412371000 UDI-DI: 5707480145737 1 each 5707480145744 5 pc/pack Catalog No. 412391000 UDI-DI: 5707480145768 1 each 5707480145775 5 pc/pack Catalog No. 412411000 UDI-DI: 5707480145799 1 each 5707480145805 5 pc/pack All lots
Quantity Affected: 12,921
Reason for Recall
Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.
Distribution
Domestic distribution nationwide. Foreign distribution to Austria, Belgium, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norge, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, UK Canada, Australia, New Zealand, Israel .
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-03
Company
Columbia, MD
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 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ambu Inc. has 6 FDA actions in our database, including 6 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 (Ambu Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ambu Inc. have FDA actions?
Ambu Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1420-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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