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U.S. Department of Health and Human Services

Class 1 Device Recall BD Alaris Pump Module Model 8100

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 Class 1 Device Recall BD Alaris Pump Module Model 8100see related information
Date Initiated by FirmJuly 08, 2025
Date PostedAugust 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2179-2025
Recall Event ID 97067
510(K)NumberK211218 
Product Classification Pump, infusion - Product Code FRN
ProductBD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Code Information BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information ContactBD Technical Support
888-812-3229
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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce33,162,680 units total
DistributionUS 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
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = FRN
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