AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on me
Summary
The FDA issued a Class II for AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 2 by Avanos Medical, Inc.. Reason: Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); howev.
Details
Source
Device Recall
External ID
Z-0360-2024
Action Date
2023-11-29
Status
Ongoing
Category
device
Product Description
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Lot/Code Info: UDI/DI 00609038945064, Lot Numbers: 30112716, 30122936, 30116495, 30122179, 30116496, 30124942, 30117487, 30126227, 30117488, 30124946, 30117632, 30127429, 30117633, 30127494, 30113925, 30137504, 30119101, 30153170, 30119102, 30151042, 30116223, 30194152, 30123991
Quantity Affected: 4730 cases (94600 devices)
Reason for Recall
Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.
Distribution
US and South Africa
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-13
Company
Alpharetta, GA
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 167 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 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 (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-0360-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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