Reported Dec 13, 2023 · Ongoing
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15…
B. Braun Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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. · 901 Marcon Blvd · Allentown, PA · 18109-9512
Is this the product you have?
- Infusomat
- Administration Sets as listed below362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL
- priming volume22mL
- length
119inSafeLine362033 UNIV. 15 DR PUMP SET1.2 FIL2 CRSITE362034
- Priming volume19mL
- length
120inSafeLine362035 INFUSOMAT SPACE PUMP IV SET362043
- Priming volume39mL
- length
120inSafeLine362050 15 drops/mL
- priming volume26mL
- length
124inSafeLine362420 SPACE PUMP SET 15 DROP W/2 SAFEDAY362432 15 drops/mL
- priming volume21mL
- length
118inULTRASITE362911
- Priming volume14mL
- length84in, CARESITE, Spin-Lock; 363010
- Priming volume21mL
- length
121inSafeLine363019
- Priming volume40mL
- length
123inSafeLine363030 15 drops/mL
- priming volume22mL
- length
119inSafeLine363032 20 drops/mL
- priming volume20mL
- length
119inSafeLine363230 15 drops/mL
- priming volume22mL
- length
123inULTRASITE363410 15 drops/mL
- priming volume23mL
- length
119inCARESITE363419
- Priming volume41mL
- length
120inCARESITE363420 15 drops/mL
- priming volume24mL
- length
120inCARESITE363421 15 drops/mL
- priming volume22mL
- length
120inCARESITE363422
- Priming volume21mL
- length
130inCARESITE363423 60 drops/mL
- priming volume21mL
- length
118inCARESITE363424 UNIV. 15 DR PUMP SET1.2FIL2CRSTE ASV363430 15 drops/mL
- priming volume23mL
- length
123inCARESITE363433 UNIV. 15 DROP PUMP SET3 CARESITEASV363901 60 drops/mL
- priming volume11mL
- length
129in363902
- Priming volume25mL
- length
130in363904 UNIV. 15 DROP PUMP SETASV470119 15 drops/mL
- priming volume23mL
- length
119inCARESITE480254 SPACE PUMP IV SET 15D110 IN480255 SPACE PUMP IV SET127 IN480257 60 DROP NITRO SPACE SET88 IN480258 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER480263 SPACE PUMP IV SET 15D90 IN480264 SPACE PUMP IV SET15 DRPS/ML95 IN490037
- Priming volume25mL
- length
136in490038 60 drops/mL
- priming volume11mL
- length
129in490100 15 drops/mL
- priming volume22mL
- length
120inCARESITE490101
- Priming volume19mL
- length
120inCARESITE490102 15 drops/mL
- priming volume22mL
- length
120inCARESITE490103 15 drops/mL
- priming volume24mL
- length
120inCARESITE490104 60 drops/mL
- priming volume21mL
- length
115inCARESITE490105
- Priming volume39mL
- length120in, CARESITE
- Lot codes and dates
- Material No. 362031
- UDI-DI 04046964837807 LotsMaterial No. 362032
006180981200618220060061826547006184200600618443160061850548006186307500VL88144300VL88144400VL881445
- UDI-DI 04046964182556 LotsMaterial No.362033
0061825440006182651800618411070061859898006189120600VL88144600VL88144700VL881448
- UDI-DI 04046964837821 LotsMaterial No. 362034
00618254910061832933006184101600618443190061852088006185989900618615280061880107006188829400618916130061900150
- UDI-DI 04046964182570 Lots0061809813 0061875347 0061880110 0061895436 00VL845496 Material No. 362035
- UDI-DI 04046964699047 LotsMaterial No. 362043
006181524200618207660061821992006182199300618265310061829597006183176900618329580061844310006184725500618531020061855700006186362500618883270061894407
- UDI-DI 04046964182631 LotsMaterial No. 362420
006186307636205004046964182655006182209100618405080061852666006186124400VL88140200VL88140300VL881404
- UDI-DI 04046955592715 LotsMaterial No. 362432 UDI-DI 04046964182679 Lots 0061806560 0061864982 Material No. 362911 UDI-DI 04046964837845 Lots
0061822004006182303500618230710061826688006183176100618370010061837884006183789100618429960061843033006184722200618499990061855839006185584000618599880061859990006185999100618745880061876229006188005900618832090061885064006188832300618915710061892316006189553500618956820061898768006189895000VL88087800VL88200700VL882008
Material No. 363010 UDI-DI 04046964294174 Lots 0061815475 0061822081 0061841080 0061852668 0061863624 0061875604 Material No. 363019 UDI-DI 04046964294198 Lots 0061818130 0061832938 0061865704 Material No. 363030 UDI-DI 04046964294259 Lots00618295920061847275006185208700618557020061859902006186858100618765800061878508006188006000VL86659400VL86659500VL866596
Material No. 363032 UDI-DI 04046964294297 Lots00618154760061838037006185185400618648730061892484006189568300VL81753300VL817534
Material No. 363230 UDI-DI 04046964294495 Lots00618152540061817792006183664200618410180061847266006185990300618827070061895431006190014100VL86513400VL86513500VL865136
Material No. 363410 UDI-DI 04046964294556 Lots006182307300618265270061829582006183700200618443060061855699006186202200618755960061876683006188270900618850680061894394006190157600VL86749300VL86749400VL867495
Material No. 363419 UDI-DI 04046964294570 Lots00618164720061821960006182959900618410190061846809006185310300618599040061872871006187989900618954320061901579
Material No. 363420 UDI-DI 04046964294594 Lots00618152470061819597006182203400618230760061826505006183700300618526750061854000006185405800618599050061862023006186360900618655910061869283006187529100618776130061877614006189163400VL83104100VL83104200VL83104300VL89036900VL89037000VL890371
Material No. 363421 UDI-DI 04046964294617 Lots0061818061006182307900618295860061837004006184430800618557010061861240006186857500618745320061885035
Material No. 363422 UDI-DI 04046964294631 Lots 0061815266 0061859730 0061882161 0061891576 00VL817535 00VL866368 Material No. 363423 UDI-DI 04046964294655 Lots79 of 79 codes
006181155900618143410061815238006181797700618179880061819668006182199100618230680061825476006182547800618261940061826501006182650200618266830061827330006182802300618295800061830091006183173900618320960061833564006183700500618370060061837007006183789200618411170061842994006184302900618443030061845291006184716900618471700061850000006185053200618505400061851939006185310600618556970061855830006185583100618558320061855833006185827900618582840061859442006185966300618599500061859952006186012500618618400061862010006186461200618706970061870720006187072100618707500061870848006187084900618754660061876678
Material No. 363424 UDI-DI 04046964837906 Lots00618154780061832935006183700900618443170061863077006187320600618850650061891577
Material No. 363430 UDI-DI 04046964294679 Lots006181548000618220660061826553006183359500618410200061846766006185267200618615240061870722006187683400618904070061901588
Material No. 363433 UDI-DI 04046964837920 Lots106 of 106 codes
006181155800618152350061815482006181643500618167960061817978006181799300618179940061818676006182159500618219870061821988006182306900618264990061826686006182732900618295770061831759006183297400618335660061837010006183701100618370120061837303006183789300618388700061841083006184111000618429920061843027006184430400618452890061847042006184717100618471720061847173006184828900618486620061849508006185000100618503300061850533006185054700618506260061853107006185314300618558350061855836006185583700618558380061856842006185684300618581640061858283006185922800618594440061859912006185994400618599460061859947
Material No. 363901 UDI-DI 04046964294716 Lots 0061818804 0061861261 0061863628 0061891579 0061898773 Material No. 363902 UDI-DI 04046964294730 Lots00618154840061822042006182655100618410210061852667006186253600618915780061895410006189873400VL85114600VL85114700VL851148
Material No. 363904 UDI-DI 04046964699061 Lots00618143580061820767006182201100618295910061843401006185582400618660160061879922006188826300VL86253000VL86253100VL862532
Material No. 470119 UDI-DI 04046964298714 Lots006181959500618248610061835511006183701500618430000061847230006185582500618620250061866010006187320700618760250061876420006189157000618916370061895443006189877500VL86591000VL86591100VL865912
Material No. 480254 UDI-DI 04046955324798 Lots00618230460061833291006183354600618443180061883002006188831900VL85554800VL85554900VL855550
Material No. 480255 UDI-DI 04046955324804 Lot 0061897302 Material No. 480257 UDI-DI 04046955324828 Lots00618129510061812953006182010600618207680061823072006182548500618279000061830164006183827500618558470061863078006186364500618671500061876581006187909700618799210061881414006188505900618899160061900325006190136100VL84466900VL85245500VL85245600VL852457
Material No. 480258 UDI-DI 04046955324835 Lots0061820769006182607900618265280061843406006186542700618732090061887372006188828700VL83662300VL83662400VL83662500VL85720700VL85720800VL857209
Material No. 480263 UDI-DI 04046955693931 Lots 0061874472 0061888448 0061894265 0061900139 Material No. 480264 UDI-DI 04046955778744 Lots 0061871461 0061872801 0061894264 0061898761 Material No. 490037 UDI-DI 04046964185922 Lots0061815489006182459900618295870061850550006186123900VL84705100VL84705200VL847053
Material No. 490038 UDI-DI 04046964185946 Lots006182549200618329700061837017006184341300618472360061852663006185828500618620210061870727006187459000618776250061885070006189877100VL83547800VL83547900VL835480
Material No. 490100 UDI-DI 04046964186080 Lots0061826523006183689800618434140061850530006189502200618950230061895024006190013700VL891503
Material No. 490101 UDI-DI 04046964186103 Lots362 of 362 codes
006181434300618149940061815236006181549300618164360061816798006181686200618175740061817575006181797900618179800061817996006181799700618179980061818438006181843900618184550061819064006181955100618196990061819700006182070300618215960061821597006182159800618215990061821983006182198400618219850061822585006182258600618228910061822892006182289400618230300061823067006182446000618244610061824462006182446300618245940061825229006182523000618253790061825482006182575700618260260061826191006182619200618261930061826496006182649700618266820061827324006182732600618273530061828019006182802000618295760061830088
Material No. 490102 UDI-DI 04046964186127 Lots00618366430061852089006185990800618657110061879873006187996600618832020061888317006189868100VL84191900VL84398700VL844536
Material No. 490103 UDI-DI 04046964302107 Lots294 of 294 codes
006181434400618152340061815495006181643300618164340061816799006181757600618179810061817982006181799900618180000061818001006181800200618180030061818440006181844100618187100061819705006181970600618200910061821592006182159300618219800061821981006182198200618225870061822588006182292400618230310061823066006182445800618248860061825227006182522800618254840061826189006182619000618264920061826493006182668100618273270061828017006182801800618300950061830096006183010500618316810061831734006183173500618317360061831851006183185200618335580061833559006183465000618346510061835422006183542300618363660061836367
Material No. 490104 UDI-DI 04046964186141 Lots006181434600618186270061819708006182200300618230340061823070006182654100618266870061838000006184019900618410840061842995006184303000618443050061847221006185390400618599850061859987006186461300618679000061868102006187321800618745870061875823006187767400618799680061883203006188507200618873730061889045006189157400618916160061895139006189554900VL86046000VL86046100VL86046200VL86116500VL86116600VL86116700VL86121700VL861353
Material No. 490105 UDI-DI 04046964186165 Lots00618220080061823080006182956200618370410061842985006185054400618625940061869523006187992300618916390061898725
66 of 66 codes
00618143470061816474006181801200618180130061818014006182197800618230740061824110006182471500618265430061826689006182958100618335700061837042006183789600618430320061844307006184718100618526760061853895006185389600618540720061854075006185523500618558480061857698006185869200618620820061866266006186771400618692990061870723006187072400618707470061872024006187244500618750810061875083006187528000618752810061876490006187650300618801020061883157006188506300618882860061891572006189159300618944000061894404006189869000618986940061898954006190029100VL82789900VL82791300VL82791400VL86382500VL86382600VL863827
- Amount recalled
- 33,820,976 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.
Using this product could cause serious injury, illness or death — stop using it now.
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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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