Brand Name: Ballard Product Name: Closed Suction recall: Sterility Concern
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction…
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): 1561165 Each: 00609038938349 DSP: 10609038938346 Case: 20609038938343
- Product
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction…
- Recalling firm
- Avanos Medical, Inc.
- Quantity
- 4000 units
- 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)