B. Braun Medical, Inc.: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.; Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

Agency Publication Date: September 24, 2021

Affected Products

Product: Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7453

Lot Code: 0061770205 DI: 04046964189388

Lot Numbers:

Code

Product: Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: NF3120

Lot Code: 0061769045 DI: 04046964187322

Lot Numbers:

Code

Product: Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400

Lot Code: 0061765082 DI: 04046964189258

Lot Numbers:

Code

Product: 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212

Lot Code: 0061752459 0061752460 0061755100 0061755637 0061757837 0061757838 0061758588 0061759428 0061759475 0061761605 0061765911 0061766189 0061767026 0061767841 0061769047 0061769091 0061769931 0061770185 0061770486 0061771274 0061772190 0061775452 0061776078 0061776101 0061776773 0061776915 0061777160 0061777161 0061780362 Lot Codes: 0061780840 0061781779 00VL752554 DI: 04046964293832

Lot Numbers:

Code

Codes

Product: Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413

Lot Code: 0061755638 0061757839 0061759426 0061763839 0061763893 0061763894 0061766190 0061767014 0061767027 0061768466 0061769094 0061772192 0061772193 0061775455 0061776025 0061776298 0061776299 0061776300 0061776301 0061777154 00VL752555 00VL754131 DI: 04046964182211

Lot Numbers:

Code

Product: Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214

Lot Code: 0061752471 0061756801 0061757861 0061766196 0061777798 DI: 04046964182235

Lot Numbers:

Code

Product: 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215

Lot Code: 0061758630 0061763934 DI: 04046964182259

Lot Numbers:

Code

Product: 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216

Lot Code: 0061760493 0061763906 0061764288 0061765128 0061771281 DI: 04046964182273

Lot Numbers:

Code

Product: Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118

Lot Code: 0061757772 DI: 04046964182877

Lot Numbers:

Code

Product: ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024

Lot Code: 0061770206 DI: 04046964297410

Lot Numbers:

Code

Product: V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025

Lot Code: 0061756809 0061763935 0061768485 0061777803 DI: 04046964297434

Lot Numbers:

Code

Product: OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004

Lot Code: 0061755664 0061757771 0061757873 0061763933 0061768487 0061786789 DI: 04046964857263

Lot Numbers:

Code

Product: Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005

Lot Code: 0061772234 DI: 04046955202799

Lot Numbers:

Code

Product: OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009

Lot Code: 0061783984 DI: 04046955202935

Lot Numbers:

Code

Product: PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239

Lot Code: 0061756804 0061757753 0061777804 DI: 04046955137015

Lot Numbers:

Code

Product: OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361

Lot Code: 0061757775 0061765083 0061777822 DI: 04046964642623

Lot Numbers:

Code

Product: OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490564

Lot Code: 0061769182 DI: 04046955275588

Lot Numbers:

Code

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88531

Status: Resolved

Manufacturer: B. Braun Medical, Inc.

Manufactured In: United States

Units Affected: 17 products (978,876 units; 585,576 units; 44,866 units; 1,960 units; 55,584 units; 940 units; 200 units; 12,000 units; 12,216 units; 1,752 units; 504 units; 13,320 units; 7,248 units; 768 units; 504 units; 1,080 units; 336 units)

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 · 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.

Affected Products

Lot Code: 0061770205 DI: 04046964189388

Lot Numbers:

Code

Lot Code: 0061769045 DI: 04046964187322

Lot Numbers:

Code

Product: Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400

Lot Code: 0061765082 DI: 04046964189258

Lot Numbers:

Code

Product: 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212

Lot Numbers:

Code

Codes

Lot Numbers:

Code

Lot Code: 0061752471 0061756801 0061757861 0061766196 0061777798 DI: 04046964182235

Lot Numbers:

Code

Product: 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215

Lot Code: 0061758630 0061763934 DI: 04046964182259

Lot Numbers:

Code

Product: 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216

Lot Code: 0061760493 0061763906 0061764288 0061765128 0061771281 DI: 04046964182273

Lot Numbers:

Code

Product: Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118

Lot Code: 0061757772 DI: 04046964182877

Lot Numbers:

Code

Product: ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024

Lot Code: 0061770206 DI: 04046964297410

Lot Numbers:

Code

Product: V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025

Lot Code: 0061756809 0061763935 0061768485 0061777803 DI: 04046964297434

Lot Numbers:

Code

Product: OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004

Lot Code: 0061755664 0061757771 0061757873 0061763933 0061768487 0061786789 DI: 04046964857263

Lot Numbers:

Code

Product: Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005

Lot Code: 0061772234 DI: 04046955202799

Lot Numbers:

Code

Product: OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009

Lot Code: 0061783984 DI: 04046955202935

Lot Numbers:

Code

Product: PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239

Lot Code: 0061756804 0061757753 0061777804 DI: 04046955137015

Lot Numbers:

Code

Product: OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361

Lot Code: 0061757775 0061765083 0061777822 DI: 04046964642623

Lot Numbers:

Code

Product: OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490564

Lot Code: 0061769182 DI: 04046955275588

Lot Numbers:

Code

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88531

Status: Resolved

Manufacturer: B. Braun Medical, Inc.

Manufactured In: United States