Recall Z-1756-2022— CAREFUSION

Name: FDA recall Z-1756-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-01

Class II · Ongoing

Class II FDA medical device recall by CAREFUSION, initiated 2022-08-01. It names one FDA 510(k) clearance: K051499. Product: BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436. Reason: 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..

Recalling firm: CAREFUSION
Classification: Class II
Status: Ongoing
Initiated: 2022-08-01
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K051499 — INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SETMedegen Medical Manufacturing Services·cleared 2005-06-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.