| | Class 1 Device Recall BD Alaris Pump Infusion Sets |  |
| Date Initiated by Firm | July 08, 2025 |
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| Date Posted | August 06, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2180-2025 |
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| Recall Event ID |
97067 |
| 510(K)Number | K022209 |
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| Product Classification |
Pump, infusion - Product Code FRN
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| Product | BD Alaris Pump Infusion Sets
REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV;
REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV;
REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D;
REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV;
REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2M;
REF: 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CV;
REF: 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CV;
REF: 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2M;
REF: 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesAS LVP 20D CV;
REF: 10561554, BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D DEHP FREE 3SS 15M CV;
REF: 10863358, BD Alaris Pump Infusion Set, 15 Micron FilterAS LVP 20D DEHP FREE 15M;
REF: 11171447, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 20D 3SS 2CV;
REF: 11532269, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sitesAS LVP 20D PE-LINED 2SS 0.2M CV;
REF: 10010454, BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-siteAS LVP 20D PE-LINED TUBING SS 0.2M;
REF: 2465-0007, BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, Low Sorbing Tubing (PE Lined), SmartSite Y-siteAS LVP SS BAG 20D PE-Lined SS 0.2M;
REF: 10010453, ASBD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site LVP 20D PE-LINED TUBING SS 1.2M
REF: 11419365, BD Alaris" Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite" Y-sites
REF: 10813621, BD Alaris" Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites
REF: 2423-0007, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites
REF: 10015896, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite" Y-sites
REF: 24010-0007T, BD Alaris" Pump Infusion Set, Bonded Texium", Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite" Y-sites
REF: 10010483, BD Alaris" Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing
REF: 2403-0007, BD Alaris" Pump Infusion Set, Half Set, SmartSite" Y-site
REF: 24301-0007T, BD Alaris" Pump Infusion Set, SmartSite" Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium" Closed Male Luer with Priming Cap, SmartSite" Y-site |
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| Code Information |
REF: 10013186/ UDI: 07613203021173;
REF: 2452-0007/ UDI: 10885403219870;
REF: 2204-0007/ UDI: 10885403199363;
REF: 24001-0007/ UDI: 10885403238666;
REF: 10015012/ UDI: 10885403233951;
REF: 2432-0007/ UDI: 10885403232329;
REF: 2434-0007/ UDI: 07613203019682;
REF: 2202-0007/ UDI: 10885403274039;
REF: 11426965/ UDI: 10885403232558;
REF: 10561554/ UDI: 10885403232565;
REF: 10863358/ UDI: 10885403232466;
REF: 11171447/ UDI: 07613203021234;
REF: 11532269/ UDI: 10885403232343;
REF: 10010454/ UDI: 07613203015806;
REF: 2465-0007/ UDI: 10885403221941;
REF: 10010453/ UDI: 07613203021135
REF: 11419365/ UDI: 10885403234736
REF: 10813621/UDI: 10885403234514
REF: 2423-0007/UDI: 07613203020985
REF: 10015896/UDI: 10885403234064
REF: 24010-0007T/UDI: 10885403271021
REF: 10010483/UDI: 10885403232602
REF: 2403-0007/UDI: 10885403232473
REF: 24301-0007T/UDI: 10885403223198 |
Recalling Firm/
Manufacturer |
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
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| For Additional Information Contact | BD Technical Support
888-812-3229 |
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Manufacturer Reason
for Recall | Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | On July 8, 2025, CareFusion 303, Inc. (BD) issued an "Urgent Medical Device Recall (correction)" notification via Fed Ex and email. On July 17, 2025, CareFusion expanded their recall due to the inadvertent omission of 8 SKUs from the Attachment A. CareFusion ask consignees to take the following actions:
1. Devices can continue to be used as intended. Please refer to Mitigations referenced in the letter.
2. Refer to Attachment B for the new set performance data as compared to the existing set performance data found in your User Manuals.
3. Post this Customer Notification on or near the affected products. If you experience any issues, contact BD at productcomplaints@bd.com
4. Please review your clinical procedures to confirm if the affected compatible Pump Infusion Sets are used as part of your clinical practice.
5. Circulate this notice within your facility network to ensure that all concerned personnel are made aware of this issue.
6. Complete the attached Customer Response Form and return to the BD contact via fax at: (312) 949-0068 or email at: BDRC49@bd.com whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification.
If you require further assistance, please contact: BD Technical Support at Phone: 888-812-3229; Phone hours: 6:00am to 5:00pm PT Monday Friday and Email: DL-US-INF-TechSupport@bd.com. |
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| Quantity in Commerce | 33,162,680 units total |
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| Distribution | US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MP MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = FRN
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