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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

B. Braun Medical, Inc.: Infusomat Administration Sets Recalled for Tubing Defects and Infusion Errors

Agency Publication Date: December 1, 2023
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Summary

B. Braun Medical, Inc. is recalling 33,820,976 units of Infusomat Administration Sets due to defects where the tubing diameter is incorrect or the tubing length is too short. These defects can trigger false air-in-line alarms, which automatically stop the infusion pump and interrupt the delivery of critical medications. These medical devices were distributed nationwide in the U.S., as well as in Canada and Germany, through various hospital and clinical channels.

Risk

If the pump stops during the administration of life-sustaining medications, such as vasopressors for hemodynamically unstable patients, it can cause serious injury or death. The tubing defect prevents the device from accurately sensing air or maintaining steady flow, leading to immediate therapy interruptions.

What You Should Do

  1. Locate your Infusomat Administration Sets and check the packaging for 'Material Numbers' and 'Lot Numbers' to see if your supply is affected.
  2. Identify affected Material Numbers, which include 362031, 362032, 362033, 362034, 362035, 362043, 362050, 362420, 362432, 362911, 363010, 363019, 363030, 363032, 363230, 363410, 363419, 363420, 363421, 363422, 363423, 363424, 363430, 363433, 363901, 363902, 363904, 470119, 480254, 480255, 480257, 480258, 480263, 480264, 490037, 490038, 490100, 490101, 490102, 490103, 490104, and 490105.
  3. Match the Lot Numbers on your specific sets against the extensive list of recalled codes, such as 0061809812, 00VL881443, 0061825440, and 00VL881446 (refer to the manufacturer's notification for the full list of over 1,000 affected lots).
  4. Verify the UDI-DI codes on the product label, such as 04046964837807 (Material 362031) or 04046964186165 (Material 490105).
  5. Contact your healthcare provider or B. Braun Medical, Inc. at 1-800-227-2862 for specific instructions on returning defective sets and obtaining replacements.
  6. Report any adverse events or quality problems experienced with the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
  7. For additional questions regarding this device recall, contact the FDA hotline at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Device Exchange

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Infusomat Space Pump Set with Caresite Injection Site
Model / REF:
362031
UPC Codes:
04046964837807
Lot Numbers:
0061809812
0061822006
0061826547
0061842006
0061844316
0061850548
0061863075
00VL881443
00VL881444
00VL881445
Product: Infusomat Space Pump Set 15 drops/mL (119in)
Model / REF:
362032
UPC Codes:
04046964182556
Lot Numbers:
0061825440
0061826518
0061841107
0061859898
0061891206
00VL881446
00VL881447
00VL881448
Product: Infusomat Space Pump Set 15 drops/mL (120in) Caresite
Model / REF:
490100
UPC Codes:
04046964186080
Lot Numbers:
0061814343
0061814994
0061815236
0061815493
00VL887228
00VL887229
00VL887230
Product: Infusomat Space Pump IV Set (127in)
Model / REF:
480255
UPC Codes:
04046955324804
Lot Numbers:
0061897302

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93232
Status: Active
Manufacturer: B. Braun Medical, Inc.
Sold By: B. Braun Medical distributors; hospitals; clinical providers
Manufactured In: United States
Units Affected: 33,820,976 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.