FDA (Devices) recall action 94823

B. Braun Medical, Inc. recalled 29 products on 2024-07-24

The FDA (Devices) publishes a recall like this one as 29 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 29 pages.

Products: 29
Announced: 2024-07-24
Critical: 0
Units: 17,981,522

Why these products were recalled

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 29

HighFDA (Devices)··2024-07-24
IV Infusion Pump Sets Recalled for Backcheck Valve Malfunction
B. Braun is recalling Infusomat IV infusion pump sets due to potential backcheck valve malfunction that can cause medication to flow backward between IV containers and prevent proper medication delivery.
Product
Infusomat 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
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
Infusomat UNIV. 15 IV Pump Set Recalled for Backflow Hazard
B. Braun Medical is recalling 32,752 units of the Infusomat UNIV. 15 DR pump tubing set due to potential backcheck valve malfunction that could cause medication backflow between IV containers and medication loss.
Product
Infusomat 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
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
IV Pump Sets Recalled for Potential Backcheck Valve Malfunction
B. Braun Infusomat SPACE IV pump sets may experience backcheck valve malfunction, causing medication backflow between containers and preventing proper IV line priming. This could result in adverse drug reactions, incorrect medication doses, or medication loss.
Product
Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362432
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Distribution
0 states
HighFDA (Devices)··2024-07-24
IV Infusion Pump Set Recalled for Backflow Risk During Medication Administration
B. Braun Medical is recalling the OUTLOOK PUMP SET 3 IV infusion sets due to a potential backcheck valve malfunction that could cause medication to backflow from secondary containers into primary containers, risking adverse drug reactions and medication loss.
Product
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
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Distribution
0 states
HighFDA (Devices)··2024-07-24
Infusomat SPACE Pump IV Sets Recalled for Backcheck Valve Malfunction
B. Braun's Infusomat SPACE Pump IV sets are recalled due to a potential backcheck valve malfunction that could cause medication backflow and inability to prime. The defect affects approximately 109,464 units distributed in the US and Canada.
Product
Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480254
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Distribution
0 states
HighFDA (Devices)··2024-07-24
Infusomat SPACE IV infusion sets recalled for backcheck valve malfunction
Infusomat SPACE IV infusion sets are recalled due to a backcheck valve defect that may cause medication to flow backward into primary IV bags, potentially resulting in medication loss or adverse drug reactions.
Product
Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 480263
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Distribution
0 states
HighFDA (Devices)··2024-07-24
Infusion Pump Set Recalled Due to Valve Malfunction Risk
B. Braun's Infusomat UNIV. 60 infusion pump sets are recalled due to backcheck valve malfunction that may cause medication backflow from secondary to primary IV bags, risking adverse drug reactions or medication loss.
Product
Infusomat 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
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
Infusomat IV Pump Set Recalled for Backcheck Valve Malfunction
The Infusomat 60DROP METRISET PUMP SET may experience backcheck valve malfunction, causing medication to flow backward between IV containers and loss of medication. This could result in adverse drug reactions or inability to administer medication properly.
Product
Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362034
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
Infusion Pump Set Recalled for Potential Backcheck Valve Malfunction and Medication Backflow
B. Braun's Infusomat UNIV. 15 IV infusion pump set is being recalled due to a potential backcheck valve malfunction that could cause medication to backflow from secondary into primary IV containers, potentially resulting in patient injury.
Product
Infusomat 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
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
IV Infusion Pump Set Backcheck Valve Malfunction Recall
B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET due to backcheck valve malfunction that could cause medication backflow and loss of medication, resulting in adverse drug reactions.
Product
Infusomat 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
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
Infusion Pump Sets Recalled for Potential Backflow of Medication
B. Braun is recalling Infusomat UNIV. 15 IV pump sets due to a backcheck valve malfunction that could divert medication between containers and prevent proper priming.
Product
Infusomat 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
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
Infusomat UNIV. 15 IV Pump Set Recalls Due to Backcheck Valve Malfunction
B. Braun is recalling Infusomat UNIV. 15 IV pump sets because the backcheck valve may malfunction, potentially causing medication backflow or loss, which could lead to adverse drug reactions.
Product
Infusomat 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
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
B. Braun Infusomat SPACE IV Set Backcheck Valve Malfunction Recall
B. Braun Medical is recalling 68,205 Infusomat SPACE IV Sets due to a potential backcheck valve malfunction that could allow medication backflow between IV containers.
Product
Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363420
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
Infusomat SPACE IV Pump Set Recalled for Backcheck Valve Malfunction
B. Braun is recalling Infusomat SPACE IV pump sets due to a backcheck valve malfunction that could cause medication to flow backward into the primary IV container and prevent proper priming of the line.
Product
Infusomat 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
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
Infusion pump set backcheck valve malfunction may prevent medication delivery
B. Braun Medical is recalling an infusion pump set due to potential backcheck valve malfunction that could cause medication to flow backward into IV containers and prevent proper medication administration. The recall affects 3,624 units distributed worldwide.
Product
Infusomat 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
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Distribution
0 states
HighFDA (Devices)··2024-07-24
IV Pump Infusion Set Backcheck Valve May Malfunction and Cause Medication Backflow
B. Braun is recalling the Infusomat UNIV.15DROP PUMP SET (Model 362032) because the backcheck valve may malfunction, allowing medication to flow backward from secondary to primary IV containers, risking medication loss and adverse drug reactions.
Product
Infusomat 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
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
IV infusion set recalled due to backcheck valve malfunction
B. Braun is recalling OUTLOOK IV sets due to potential backcheck valve malfunction that could allow medication to flow backward between IV containers and prevent proper priming, potentially resulting in patient injury.
Product
OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354212
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Distribution
0 states
HighFDA (Devices)··2024-07-24
IV Infusion Pump Set Recalled for Backcheck Valve Malfunction Risk
B. Braun is recalling the Infusomat UNIV. 15 DROP PUMP SET due to potential backcheck valve malfunction that could cause medication backflow and loss. The defect may result in adverse drug reactions or improper medication delivery.
Product
Infusomat 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
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
Infusion pump IV administration set recalled for backcheck valve malfunction risk
B. Braun is recalling Infusomat UNIV. 15 DROP PUMP SET infusion sets due to potential backcheck valve malfunction that may cause medication to flow backward into primary IV containers and prevent proper priming, risking adverse drug reactions.
Product
Infusomat 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
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
IV Infusion Pump Set Recalled for Medication Backflow Risk
B. Braun's Infusomat 60 IV infusion pump set is being recalled due to a backcheck valve that may malfunction, allowing medication to flow backward between IV containers and preventing proper priming of the line.
Product
Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490101
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
Infusion Pump Component Valve Malfunction May Cause Medication Backflow
B. Braun's Infusomat infusion pump component can malfunction, causing medication to flow backward from secondary IV lines into primary lines, potentially resulting in improper medication delivery and patient harm.
Product
Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363422
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
IV Infusion Pump Set Valve May Cause Dangerous Medication Backflow
B. Braun's Infusomat pump sets may have faulty backcheck valves causing medication to backflow between IV bags, risking reduced medication delivery and adverse reactions. All units distributed worldwide after August 2023 are affected.
Product
Infusomat 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
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Distribution
0 states
HighFDA (Devices)··2024-07-24
Infusomat SPACE Pump IV Set Recalled Due to Backcheck Valve Malfunction
B. Braun Medical is recalling the Infusomat SPACE IV pump set (Model 480255) due to potential backcheck valve malfunction that could allow medication to flow backward between IV containers, potentially causing adverse drug reactions or loss of medication.
Product
Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480255
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
B. Braun Infusomat IV Pump Set Recalled Due to Backflow Risk
B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET units due to a potential backcheck valve malfunction that could cause medication backflow and adverse drug reactions.
Product
Infusomat 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
Category
Distribution
0 states
HighFDA (Devices)··2024-07-24
B. Braun Infusomat 60 IV Pump Sets Recalled for Backcheck Valve Malfunction
B. Braun is recalling Infusomat 60 infusion pump sets (Model 363010) due to potential backcheck valve malfunction. The defect could cause medication to flow backward into primary IV containers and prevent proper medication delivery.
Product
Infusomat 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
Category
Distribution
0 states