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U.S. Department of Health and Human Services

Class 2 Device Recall AVANOS BALLARD Closed Suction System for Adults 14 Fr, DSE, MDI

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  Class 2 Device Recall AVANOS BALLARD Closed Suction System for Adults 14 Fr, DSE, MDI see related information
Date Initiated by Firm October 13, 2023
Date Posted November 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-0360-2024
Recall Event ID 93305
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
Product AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Code Information 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
Recalling Firm/
Manufacturer		 Avanos Medical, Inc.
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact
470-448-5591
Manufacturer 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.
FDA Determined
Cause 2		 Labeling Change Control
Action Avanos medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/13/2023 via FedEx. The notice explained the issue, potential risk to health, and requested that the product be destroyed at the consignee. Distributors were directed to notify their customers.
Quantity in Commerce 4730 cases (94600 devices)
Distribution US and South Africa
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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