Reported Dec 3, 2025 · Ongoing

Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space…

B Braun Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: B Braun Medical Inc · 824 12th Ave · Bethlehem, PA · 18018-3524

Is this the product you have?

27 of 27 products

Products covered by this recall
Model / number	Product as published
`362032.`	UNIV.15DROP PUMP SET W/3 SAFELINE LL; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine
`362033.`	UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE
`362034.`	60DROP METRISET PUMP SET, 3 SAFELINE; Priming volume: 19mL, length: 120in, SafeLine
`362043.`	Y TYPE BLOOD PUMP SET, SAFELINE INJ; Priming volume: 39mL, length: 120in, SafeLine¿
`362050.`	UNIV. 15 DROP PUMP SET W/ 0.2 FILTER; 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine
`362420.`	SPACE PUMP SET 15 DROP W/2 SAFEDAY; SPACE PUMP SET 15 DROP W/2 SAFEDAY
`362431.`	UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL; 15 drops/mL, priming volume: 21mL, length: 120in, ULTRASITE
`362432.`	SPACE PUMP IV SET, 120 IN.; 15 drops/mL, priming volume: 21mL, length: 118in, ULTRASITE
`363010.`	60 DROP METRISET PUMP SET,3 SFLINE ASV; Priming volume: 21mL, length: 121in, SafeLine
`363019.`	Y-TYPE BLOOD PUMP SET, SAFELINE, ASV; Priming volume: 40mL, length: 123in, SafeLine
`363030.`	UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine
`363230.`	UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV; 15 drops/mL, priming volume: 22mL, length: 123in, ULTRASITE
`363419.`	Y-TYPE BLOOD PUMP SET, CARESITE, ASV; Priming volume: 41mL, length: 120in, CARESITE
`363420.`	SPACE PUMP IV SET, 2 CARESITES, ASV; 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE
`363421.`	UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV; 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE
`363422.`	60DROP METRISET PUMP, 3 CARESITES, ASV; Priming volume: 21mL, length: 130in, CARESITE
`363423.`	UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV; 60 drops/mL, priming volume: 21mL, length: 118in, CARESITE
`363424.`	UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV
`363430.`	UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; 15 drops/mL, priming volume: 23mL, length: 123in, CARESITE
`363433.`	UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV

Lot codes and dates: 32 of 32 products
Products covered by this recall
Model / number Barcodes Product as published
362032 0404696418255604046964182549 Primary UDI-DI: 04046964182556; Unit of Dose UDI-DI: 04046964182549. Shelf Life: Earliest Exp of Comp or 60mths.
362033 0404696483782104046964837814 Primary UDI-DI: 04046964837821; Unit of Dose UDI-DI: 04046964837814. Shelf Life: Earliest Exp of Comp or 36mths.
362034 0404696418257004046964182563 Primary UDI-DI: 04046964182570; Unit of Dose UDI-DI: 04046964182563. Shelf Life: Earliest Exp of Comp or 48mths.
362043 0404696418263104046964182624 Primary UDI-DI: 04046964182631; Unit of Dose UDI-DI: 04046964182624. Shelf Life: Earliest Exp of Comp or 60mths.
362050 0404696418265504046964182648 Primary UDI-DI: 04046964182655; Unit of Dose UDI-DI: 04046964182648. Shelf Life: Earliest Exp of Comp or 60mths.
362420 0404695559271504046955592708 Primary UDI-DI: 04046955592715; Unit of Dose UDI-DI: 04046955592708. Shelf Life: 36mths from Start Date.
362431 0404696429401304046964294006 Primary UDI-DI: 04046964294013; Unit of Dose UDI-DI: 04046964294006. Shelf Life: Earliest Exp of Comp or 60mths.
362432 0404696418267904046964182662 Primary UDI-DI: 04046964182679; Unit of Dose UDI-DI: 04046964182662. Shelf Life: Earliest Exp of Comp or 60mths.
363010 0404696429417404046964294167 Primary UDI-DI: 04046964294174; Unit of Dose UDI-DI: 04046964294167. Shelf Life: Earliest Exp of Comp or 48mths.
363019 0404696429419804046964294181 Primary UDI-DI: 04046964294198; Unit of Dose UDI-DI: 04046964294181. Shelf Life: Earliest Exp of Comp or 60mths.
363030 0404696429425904046964294242 Primary UDI-DI: 04046964294259; Unit of Dose UDI-DI: 04046964294242. Shelf Life: Earliest Exp of Comp or 60mths.
363230 0404696429449504046964294488 Primary UDI-DI: 04046964294495; Unit of Dose UDI-DI: 04046964294488. Shelf Life: Earliest Exp of Comp or 60mths.
363419 0404696429457004046964294563 Primary UDI-DI: 04046964294570; Unit of Dose UDI-DI: 04046964294563. Shelf Life: Earliest Exp of Comp or 36mths.
363420 0404696429459404046964294587 Primary UDI-DI: 04046964294594; Unit of Dose UDI-DI: 04046964294587. Shelf Life: Earliest Exp of Comp or 36mths.
363421 0404696429461704046964294600 Primary UDI-DI: 04046964294617; Unit of Dose UDI-DI: 04046964294600. Shelf Life: Earliest Exp of Comp or 36mths.
363422 0404696429463104046964294624 Primary UDI-DI: 04046964294631; Unit of Dose UDI-DI: 04046964294624. Shelf Life: Earliest Exp of Comp or 36mths.
363423 0404696429465504046964294648 Primary UDI-DI: 04046964294655; Unit of Dose UDI-DI: 04046964294648. Shelf Life: Earliest Exp of Comp or 36mths.
363424 0404696483790604046964837890 Primary UDI-DI: 04046964837906; Unit of Dose UDI-DI: 04046964837890. Shelf Life: Earliest Exp of Comp or 36mths.
363430 0404696429467904046964294662 Primary UDI-DI: 04046964294679; Unit of Dose UDI-DI: 04046964294662. Shelf Life: 36mths from Start Date.
363433 0404696483792004046964837913 Primary UDI-DI: 04046964837920; Unit of Dose UDI-DI: 04046964837913. Shelf Life: Earliest Exp of Comp or 36mths.
Page 1 of 2
Amount recalled: 49,330,370

This recall covers 116 products

The agency filed one notice per product. You are reading one of them; the other 115 are below.

103 more are in the archive.

Why it was recalled

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from B Braun Medical Inc.

25 in total.

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Model / number	Barcodes	Product as published
`362032`	`0404696418255604046964182549`	Primary UDI-DI: 04046964182556; Unit of Dose UDI-DI: 04046964182549. Shelf Life: Earliest Exp of Comp or 60mths.
`362033`	`0404696483782104046964837814`	Primary UDI-DI: 04046964837821; Unit of Dose UDI-DI: 04046964837814. Shelf Life: Earliest Exp of Comp or 36mths.
`362034`	`0404696418257004046964182563`	Primary UDI-DI: 04046964182570; Unit of Dose UDI-DI: 04046964182563. Shelf Life: Earliest Exp of Comp or 48mths.
`362043`	`0404696418263104046964182624`	Primary UDI-DI: 04046964182631; Unit of Dose UDI-DI: 04046964182624. Shelf Life: Earliest Exp of Comp or 60mths.
`362050`	`0404696418265504046964182648`	Primary UDI-DI: 04046964182655; Unit of Dose UDI-DI: 04046964182648. Shelf Life: Earliest Exp of Comp or 60mths.
`362420`	`0404695559271504046955592708`	Primary UDI-DI: 04046955592715; Unit of Dose UDI-DI: 04046955592708. Shelf Life: 36mths from Start Date.
`362431`	`0404696429401304046964294006`	Primary UDI-DI: 04046964294013; Unit of Dose UDI-DI: 04046964294006. Shelf Life: Earliest Exp of Comp or 60mths.
`362432`	`0404696418267904046964182662`	Primary UDI-DI: 04046964182679; Unit of Dose UDI-DI: 04046964182662. Shelf Life: Earliest Exp of Comp or 60mths.
`363010`	`0404696429417404046964294167`	Primary UDI-DI: 04046964294174; Unit of Dose UDI-DI: 04046964294167. Shelf Life: Earliest Exp of Comp or 48mths.
`363019`	`0404696429419804046964294181`	Primary UDI-DI: 04046964294198; Unit of Dose UDI-DI: 04046964294181. Shelf Life: Earliest Exp of Comp or 60mths.
`363030`	`0404696429425904046964294242`	Primary UDI-DI: 04046964294259; Unit of Dose UDI-DI: 04046964294242. Shelf Life: Earliest Exp of Comp or 60mths.
`363230`	`0404696429449504046964294488`	Primary UDI-DI: 04046964294495; Unit of Dose UDI-DI: 04046964294488. Shelf Life: Earliest Exp of Comp or 60mths.
`363419`	`0404696429457004046964294563`	Primary UDI-DI: 04046964294570; Unit of Dose UDI-DI: 04046964294563. Shelf Life: Earliest Exp of Comp or 36mths.
`363420`	`0404696429459404046964294587`	Primary UDI-DI: 04046964294594; Unit of Dose UDI-DI: 04046964294587. Shelf Life: Earliest Exp of Comp or 36mths.
`363421`	`0404696429461704046964294600`	Primary UDI-DI: 04046964294617; Unit of Dose UDI-DI: 04046964294600. Shelf Life: Earliest Exp of Comp or 36mths.
`363422`	`0404696429463104046964294624`	Primary UDI-DI: 04046964294631; Unit of Dose UDI-DI: 04046964294624. Shelf Life: Earliest Exp of Comp or 36mths.
`363423`	`0404696429465504046964294648`	Primary UDI-DI: 04046964294655; Unit of Dose UDI-DI: 04046964294648. Shelf Life: Earliest Exp of Comp or 36mths.
`363424`	`0404696483790604046964837890`	Primary UDI-DI: 04046964837906; Unit of Dose UDI-DI: 04046964837890. Shelf Life: Earliest Exp of Comp or 36mths.
`363430`	`0404696429467904046964294662`	Primary UDI-DI: 04046964294679; Unit of Dose UDI-DI: 04046964294662. Shelf Life: 36mths from Start Date.
`363433`	`0404696483792004046964837913`	Primary UDI-DI: 04046964837920; Unit of Dose UDI-DI: 04046964837913. Shelf Life: Earliest Exp of Comp or 36mths.