FDAClass IApril 23, 2025

Brand Name: Ballard Product Name: Closed Suction recall: Sterility Concern

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard…

Why was Brand Name: Ballard Product Name: Closed Suction recalled?

Lack of sterility assurance for closed suction catheter systems

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: Lot/ Serial Number(s): 1555426 Each: 00609038982649 DSP: 10609038982646 Case: 20609038982643

Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard…
Recalling firm
Avanos Medical, Inc.
Quantity
0
Distribution
Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN,KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, Guadalajara.
Recall date
April 23, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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