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U.S. Department of Health and Human Services

Class 1 Device Recall Infusomat

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  Class 1 Device Recall Infusomat see related information
Date Initiated by Firm September 21, 2023
Date Posted October 25, 2023
Recall Status1 Open3, Classified
Recall Number Z-0123-2024
Recall Event ID 92978
510(K)Number K191910  K142596  
Product Classification Pump, infusion - Product Code FRN
Product 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Code Information UDI-DI: 04046964660887 Serial Numbers: 868497 -892669
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact BBMI Postmarket Surveillance Department
833-425-1464
Manufacturer Reason
for Recall		 Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.
FDA Determined
Cause 2		 Component design/selection
Action On September 21, 2023, the firm began notifying customers of the issue via "URGENT MEDICAL DEVICE CORRECTION" letters. BBMI will schedule service to update impacted devices. Customers were provided with stickers to identify affected units while waiting for the service to be completed. In the meantime, customers were informed of measures that may aid in continued use of the pumps, such as only using non-impacted devices for the delivery of high-risk medications and placing the impacted units in care areas that do not administer high risk medications. Customers may contact BBMI by calling 1-800-627-7867 (1-800-627-PUMP) for technical support for potential alternate interim measures.
Quantity in Commerce 9771
Distribution Domestic distribution nationwide. Foreign distribution to Canada.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FRN and Original Applicant = B. Braun Medical Inc.
510(K)s with Product Code = FRN and Original Applicant = B. Braun Melsugen AG
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