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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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High RiskFDA Device
Medical Devices/Surgical Equipment

B. Braun Medical, Inc.: IV Administration Pump Sets Recalled for Backcheck Valve Malfunction

Agency Publication Date: July 17, 2024
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Summary

B. Braun Medical, Inc. is recalling nearly 18 million various Outlook and Infusomat IV Administration Pump Sets due to a potential defect in the backcheck valve. The defect can cause medication intended for a secondary (piggyback) container to flow backward into the primary container or prevent the device from being properly primed. This malfunction has resulted in reports of adverse drug reactions and loss of medication or blood, affecting over 25 different models distributed globally including in the United States and Canada.

Risk

A malfunctioning backcheck valve allows medication to flow in the wrong direction or prevents the IV line from clearing air (priming), which can lead to patients receiving incorrect drug dosages or experiencing adverse reactions from unintended medication mixtures.

What You Should Do

  1. Identify if you have any of the 28 affected models, which include various Outlook IV sets and Infusomat pump sets with catalog numbers such as 354212, 354213, 362032, 362033, 362034, 362050, 362420, 362431, 362432, 363010, 363030, 363420, 363421, 363422, 363423, 363424, 363430, 363433, 480254, 480255, 480263, 490100, 490101, 490102, 490103, 490104, 490361, 363230, and 490564.
  2. Check the product packaging for distribution dates; all affected units were distributed after August 1, 2023 (or specific dates in August/September 2023 depending on the model).
  3. Verify the UDI-DI numbers on your device packaging against the official recall list, which includes identifiers such as 04046964293832, 04046964182211, and 04046964186080 among others.
  4. Immediately contact your healthcare provider if you believe you or a patient has experienced an adverse reaction or device malfunction related to these IV sets.
  5. Contact B. Braun Medical, Inc. directly for specific instructions on how to handle affected inventory and to discuss potential replacements or refunds.
  6. For additional questions or to report further incidents, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: OUTLOOK IV SET 15DROP W/2 CARESITE
Model / REF:
354212
UPC Codes:
04046964293832
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: OUTLOOK IV SET 15DROP W/3 CARESITE
Model / REF:
354213
UPC Codes:
04046964182211
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL
Model / REF:
362032
UPC Codes:
04046964182556
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE
Model / REF:
362033
UPC Codes:
04046964837821
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE
Model / REF:
362034
UPC Codes:
04046964182570
Lot Numbers:
All Lots Distributed After 10AUG2023
Date Ranges: Distributed After 10AUG2023
Product: Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER
Model / REF:
362050
UPC Codes:
04046964182655
Lot Numbers:
All Lots Distributed After 08AUG2023
Date Ranges: Distributed After 08AUG2023
Product: Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY
Model / REF:
362420
UPC Codes:
04046955592715
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL
Model / REF:
362431
UPC Codes:
04046964294013
Lot Numbers:
All Lots Distributed After 02AUG2023
Date Ranges: Distributed After 02AUG2023
Product: Infusomat SPACE PUMP IV SET, 120 IN.
Model / REF:
362432
UPC Codes:
04046964182679
Lot Numbers:
All Lots Distributed After 02AUG2023
Date Ranges: Distributed After 02AUG2023
Product: Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV
Model / REF:
363010
UPC Codes:
04046964294174
Lot Numbers:
All Lots Distributed After 05SEP2023
Date Ranges: Distributed After 05SEP2023
Product: Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV
Model / REF:
363030
UPC Codes:
04046964294259
Lot Numbers:
All Lots Distributed After 02AUG2023
Date Ranges: Distributed After 02AUG2023
Product: Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV
Model / REF:
363420
UPC Codes:
04046964294594
Lot Numbers:
All Lots Distributed After 02AUG2023
Date Ranges: Distributed After 02AUG2023
Product: Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV
Model / REF:
363421
UPC Codes:
04046964294617
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV
Model / REF:
363422
UPC Codes:
04046964294631
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV
Model / REF:
363423
UPC Codes:
04046964294655
Lot Numbers:
All Lots Distributed After 04AUG2023
Date Ranges: Distributed After 04AUG2023
Product: Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV
Model / REF:
363424
UPC Codes:
04046964837906
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV
Model / REF:
363430
UPC Codes:
04046964294679
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV (ASV model 363433)
Model / REF:
363433
UPC Codes:
04046964837920
Lot Numbers:
All Lots Distributed After 03AUG2023
Date Ranges: Distributed After 03AUG2023
Product: Infusomat SPACE PUMP IV SET 15D, 110 IN.
Model / REF:
480254
UPC Codes:
04046955324798
Lot Numbers:
All Lots Distributed After 02AUG2023
Date Ranges: Distributed After 02AUG2023
Product: Infusomat SPACE PUMP IV SET, 127 IN.
Model / REF:
480255
UPC Codes:
04046955324804
Lot Numbers:
All Lots Distributed After 06SEP2023
Date Ranges: Distributed After 06SEP2023
Product: Infusomat SPACE PUMP IV SET 15D, 90 IN.
Model / REF:
480263
UPC Codes:
04046955693931
Lot Numbers:
All Lots Distributed After 25SEP2023
Date Ranges: Distributed After 25SEP2023
Product: Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L.
Model / REF:
490100
UPC Codes:
04046964186080
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES
Model / REF:
490101
UPC Codes:
04046964186103
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV
Model / REF:
490102
UPC Codes:
04046964186127
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV
Model / REF:
490103
UPC Codes:
04046964302107
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ.
Model / REF:
490104
UPC Codes:
04046964186141
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: Outlook OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN.
Model / REF:
490361
UPC Codes:
04046964642623
Lot Numbers:
All Lots Distributed After 03AUG2023
Date Ranges: Distributed After 03AUG2023
Product: Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV
Model / REF:
363230
UPC Codes:
04046964294495
Lot Numbers:
All Lots Distributed After 01AUG2023
Date Ranges: Distributed After 01AUG2023
Product: OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.
Model / REF:
490564
UPC Codes:
04046955275588
Lot Numbers:
All Lots Distributed After 22AUG2023
Date Ranges: Distributed After 22AUG2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94823
Status: Active
Manufacturer: B. Braun Medical, Inc.
Sold By: Hospital supply channels; Medical device distributors
Manufactured In: United States
Units Affected: 29 products (236208 units; 88968 units; 1 unit; 47370 units; 280 units; 3624 units; 431999 units; 1152 units; 2160 units; 100 units; 37776 units; 68205 units; 1325700; 7360 units; 22560 units; 32752 units; 2085606 units; 42028 units; 109464 units; 1872 units; 13464 units; 6843513 units; 33065 units; 5672116 units; 643608 units; 59811 units; 9504 units; 158904 units; 2352 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.