8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Summary
The FDA issued a Class I for 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Inf by B. Braun Medical, Inc.. Reason: Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications m.
Details
Source
Device Recall
External ID
Z-0124-2024
Action Date
2023-11-01
Status
Ongoing
Category
device
Product Description
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Lot/Code Info: UDI-DI: 04046964708626 Serial Numbers: 878498 -881897 ***Update 8/7/24*** Additional SNs 133238, 133975, 490442, 546815, 559325, 561645, 562713, 593049, 617405, 617409, 618522, 783680, 810031
Quantity Affected: 884
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.
Distribution
Domestic distribution nationwide. Foreign distribution to Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-21
Company
Allentown, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
B. Braun Medical, Inc. has 282 FDA actions in our database, including 269 recalls and 13 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B. Braun Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B. Braun Medical, Inc. have FDA actions?
B. Braun Medical, Inc. has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0124-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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