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Use caution Medical device recall · FDA · Published June 17, 2024

B. Braun Outlook Pump Set 3 Recall: Risk of medication backflow causing patient injury

B. Braun recalls Outlook Pump Set 3 CareSite LADS 133 for potential medication backflow into IV containers, risking patient injury. Affected units distributed after August 22, 2:00 PM, 2023.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2404-2024Medical deviceB. Braun ›
Take action

Contact the company

Recalling firmB. Braun Medical, Inc.901 Marcon Blvd · Allentown, PA 18109-9512
✎ GovInfoNow plain-language explainer

B. Braun is recalling its Outlook Pump Set 3 CareSite LADS 133 IV pumps because a backcheck valve might malfunction, causing medication to flow backward into the main IV container. This could lead to patient injuries like adverse drug reactions or medication loss. Read more at govinfonow.com/recall/54799-b-braun-outlook-pump-set-3-recall-risk-of-medication.

Source Summary by GovInfoNow · govinfonow.com/recall/54799-b-braun-outlook-pump-set-3-recall-risk-of-medication · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2404-2024

Cite this page

“B. Braun Outlook Pump Set 3 Recall: Risk of medication backflow causing patient injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54799-b-braun-outlook-pump-set-3-recall-risk-of-medication. Based on FDA recall #Z-2404-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2404-2024%22&limit=1).

B. Braun Medical, Inc. recalled OUTLOOK PUMP SET 3 CARESITE LADS 133 IN. infusion sets due to a potential backflow hazard that may cause patient injuries, the FDA said on June 17, 2024.

How to tell if you have it

  • Brand: B. Braun
  • Product: OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.
  • Model/Catalog Number: 490564
  • UDI-DI: 04046955275588
  • Lot Code: Distributed After 22AUG2023
  • Units Affected: 2352

The hazard

The backcheck valve may malfunction, resulting in backflow of medication from secondary IV containers into primary IV containers and the inability to prime. This can lead to patient injuries of adverse drug reaction and/or product malfunction with loss of medication or blood.

Context

GovInfoNow's records show B BRAUN MEDICAL INC has 66 other recalls on record since October 15, 2013. Other recent recalls include a Sodium Chloride Injection recall for particulate matter hazard (August 19, 2026) and a Lactated Ringer's Injection recall for particulate matter hazard (August 12, 2026). Similar recent recalls of IV products include Windstone Custom Convenience Kits Pre Op Kit with backflow risk (March 11, 2026), Medline Kits with B. Braun IV Sets recalled due to check valve stuck (November 26, 2025), and Medline Kits with Stuck Check Valves for risk of incorrect medication delivery (November 26, 2025).

How to tell if you have this one

Check for the model number 490564 on the pump set. Units distributed after August 22, 2023, are affected. The product is used with electrically-powered IV pumps for medication administration.

  • Brand
    B. Braun
  • Category
    Medical device
FDA recall event · 29 products

All 29 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the country of Canada.
Recall numberProduct, codes & lotsQuantity
Z-2376-2024OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354212; UDI-DI 04046964293832. All Lots Distributed After 01AUG2023.236208 units
Z-2377-2024OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354213; UDI-DI 04046964182211; All Lots Distributed After 01AUG2023.88968 units
Z-2378-2024Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362032; UDI-DI 04046964182556; All Lots Distributed After 01AUG2023.1 unit
Z-2379-2024Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 362033; UDI-DI 04046964837821; All Lots Distributed After 01AUG2023.47370 units
Z-2380-2024Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362034; UDI-DI 04046964182570; All Lots Distributed After 10AUG2023.280 units
Z-2381-2024Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362050; UDI-DI 04046964182655; All Lots Distributed After 08AUG2023.3624 units
Z-2382-2024Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362420; UDI-DI 04046955592715; All Lots Distributed After 01AUG2023.431999 units
Z-2383-2024Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362431; UDI-DI 04046964294013; All Lots Distributed After 02AUG2023.1152 units
Z-2384-2024Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362432; UDI-DI 04046964182679; All Lots Distributed After 02AUG2023.2160 units
Z-2385-2024Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363010; UDI-DI 04046964294174; All Lots Distributed After 05SEP2023.100 units
Z-2386-2024Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363030; UDI-DI 04046964294259; All Lots Distributed After 02AUG2023.37776 units
Z-2387-2024Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363420; UDI-DI 04046964294594; All Lots Distributed After 02AUG2023.68205 units
Z-2388-2024Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363421; UDI-DI 04046964294617; All Lots Distributed After 01AUG2023.1325700
Z-2389-2024Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363422; UDI-DI 04046964294631; All Lots Distributed After 01AUG2023.7360 units
Z-2390-2024Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363423; UDI-DI 04046964294655; All Lots Distributed After 04AUG2023.22560 units
Z-2391-2024Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424; UDI-DI 04046964837906; All Lots Distributed After 01AUG2023.32752 units
Z-2392-2024Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363430; UDI-DI 04046964294679; All Lots Distributed After 01AUG2023.2085606 units
Z-2393-2024Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363433; UDI-DI 04046964837920; All Lots Distributed After 03AUG2023.42028 units
Z-2394-2024Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480254; UDI-DI 04046955324798; All Lots Distributed After 02AUG2023.109464 units
Z-2395-2024Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480255; UDI-DI 04046955324804; All Lots Distributed After 06SEP2023.1872 units
Z-2396-2024Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 480263; UDI-DI 04046955693931; All Lots Distributed After 25SEP2023.13464 units
Z-2397-2024Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490100; UDI-DI 04046964186080; All Lots Distributed After 01AUG2023.6843513 units
Z-2398-2024Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490101; UDI-DI 04046964186103; All Lots Distributed After 01AUG202333065 units
Z-2399-2024Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 490102; UDI-DI 04046964186127; All Lots Distributed After 01AUG2023.5672116 units
Z-2400-2024Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490103; UDI-DI 04046964302107; All Lots Distributed After 01AUG2023643608 units
Z-2401-2024Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number : 490104; UDI-DI 04046964186141; All Lots Distributed After 01AUG2023.59811 units
Z-2402-2024Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490361; UDI-DI 04046964642623; All Lots Distributed After 03AUG20239504 units
Z-2403-2024Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 363230; UDI-DI 04046964294495; All Lots Distributed After 01AUG2023158904 units
Z-2404-2024OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564; UDI-DI 04046955275588; All Lots Distributed After 22AUG2023.2352 units
Based on the official FDA remedy

What to do — step by step

  1. Check Pump Set Model

    Verify the model number on the pump set; affected units have model 490564.

  2. Contact Manufacturer

    Reach out to B. Braun Medical, Inc. for guidance on next steps if you have the affected pump set.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 37 days after the firm started it.

1. Firm started the recall: Jun 17, 202412. FDA classified it Class II: Jul 17, 202423. Published in FDA’s Enforcement Report: Jul 24, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this pump set?

Contact B. Braun Medical, Inc. to get advice on whether to stop using it or if a fix is available.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2404-2024 (June 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2404-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA