FDAClass IISeptember 28, 2022

BD MaxGuard Extension Set with 0.2 Micron Filter and recall

BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166

Why was BD MaxGuard Extension Set with 0.2 Micron Filter and recalled?

Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

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?

UDI-DI: 10885403237652, Lots: 22029648

Product
BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
Recalling firm
CAREFUSION
Quantity
600
Distribution
US: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC, IN, KY, MO, MD, PA, CA, IL, SD, GA, MS, AZ, WV, ID, WY, VT, NM, OR, NJ, OK, KS, MN
Recall date
September 28, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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