San Diego, CA, United States

CAREFUSION recalls

3 recalls recorded since 2018, most recently on 1 August 2022. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls3

Ongoing (FDA)2

Terminated or completed1

Class I (FDA)0

Recall started: 1 August 2022
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.
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
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1756-2022, Z-1760-2022, Z-1759-2022, Z-1755-2022, Z-1754-2022, Z-1758-2022, Z-1757-2022, Z-1752-2022, Z-1753-2022

BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
and 1 more product lines

Recall started: 2 August 2021
Reason: Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, PA, NC, OH, SC, IL, RI, MO, NY, TN, AL, VA, PR, CA, NE, NJ, MI, MD, NM, LA, KY, NV, ME, OK, WA, MA, WV, TX, AR, OR, KS, GA, VT, IN, WY, AZ, CO, MN, WI, UT, SD, MS, ID, MT, ND, HI, IA, DC, AK, NH, CT, DE, GU and the countries of
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2456-2021, Z-2463-2021, Z-2465-2021, Z-2459-2021, Z-2454-2021, Z-2461-2021, Z-2455-2021, Z-2458-2021, Z-2467-2021, Z-2457-2021, Z-2462-2021, Z-2468-2021 and 3 more

BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD G
BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10
BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette)
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D
BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
and 7 more product lines

Recall started: 9 June 2021
Terminated: 8 July 2024
Reason: A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
Distribution: U.S.: TN O.U.S.: None
Initiated: Voluntary: Firm initiated
Recall number: Z-1995-2021

MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.