| 2022-08-01 |
Class II
|
Ongoing |
Z-1760-2022 |
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433 |
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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 … |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1759-2022 |
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171 |
— |
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 … |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1758-2022 |
BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166 |
— |
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 … |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1757-2022 |
BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059 |
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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 … |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1756-2022 |
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, RE… |
— |
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 … |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1755-2022 |
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141 |
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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 … |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1754-2022 |
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106 |
— |
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 … |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1753-2022 |
BD MaxGuard Extension Set, REF: ME1069 |
— |
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 … |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1752-2022 |
BD MaxGuard Extension Set with 4-way stopcock, REF: M4058 |
— |
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 … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2468-2021 |
BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Va… |
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Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2467-2021 |
BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free… |
— |
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2466-2021 |
BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006 |
— |
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2465-2021 |
BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006 |
— |
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2464-2021 |
BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006 |
— |
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2463-2021 |
BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-p… |
— |
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2462-2021 |
BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564 |
— |
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2461-2021 |
BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E |
— |
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2460-2021 |
BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10… |
— |
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2459-2021 |
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: … |
— |
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2458-2021 |
BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E |
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Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2457-2021 |
BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC T… |
— |
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2456-2021 |
BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette… |
— |
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2455-2021 |
BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D |
— |
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2454-2021 |
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E |
— |
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total … |
| 2021-06-09 |
Class II
|
Terminated |
Z-1995-2021 |
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be use… |
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A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage. |