BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Summary
The FDA issued a Class I for BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold. by Avanos Medical, Inc.. Reason: Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receivin.
Details
Source
Device Recall
External ID
Z-1189-2023
Action Date
2023-03-22
Status
Terminated
Category
device
Product Description
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Lot/Code Info: All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).
Quantity Affected: 780 units
Reason for Recall
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Distribution
US Nationwide distribution in the state of Oklahoma.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-03
Company
Alpharetta, GA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Avanos Medical, Inc. has 55 FDA actions in our database, including 51 recalls and 4 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Avanos Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Avanos Medical, Inc. have FDA actions?
Avanos Medical, Inc. has 55 FDA actions in our database, including 51 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1189-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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