PlainRecalls
FDA Devices Moderate Class II Ongoing

BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436

Reported: September 28, 2022 Initiated: August 1, 2022 #Z-1756-2022

Product Description

BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436

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.

Details

Recalling Firm
CAREFUSION
Units Affected
19,925
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
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436. Recalled by CAREFUSION. Units affected: 19,925.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 28, 2022. Severity: Moderate. Recall number: Z-1756-2022.