BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
Summary
The FDA issued a Class II for BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9 by CAREFUSION. Reason: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is .
Details
Source
Device Recall
External ID
Z-1758-2022
Action Date
2022-09-28
Status
Ongoing
Category
device
Product Description
BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
Lot/Code Info: UDI-DI: 10885403237652, Lots: 22029648
Quantity Affected: 600
Reason for Recall
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-01
Company
San Diego, CA
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 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CAREFUSION has 25 FDA actions in our database, including 25 recalls.
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 (CAREFUSION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CAREFUSION have FDA actions?
CAREFUSION has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1758-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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