Use caution Medical device recall · FDA · Published August 10, 2021

B. Braun Pumps Recall: Leakage Risk in 15-Dr 3-CareSite Sets

B. Braun recalls 15-dr 3-CareSite pump sets for potential medication leakage and bloodstream infections. Affected units sold with Outlook Safety Infusion System or Horizon NXT Pump.

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

🇺🇸 FDA recall #Z-2555-2021Medical device B. Braun ›

Use caution until it’s fixed

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.

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 15-dose 3-CareSite pump sets that may leak medication, causing delays in treatment or infections. This affects users of Outlook Safety Infusion System or Horizon NXT pumps. Read more at govinfonow.com/recall/61981-b-braun-pumps-recall-leakage-risk-in-15-dr-3.

Source Summary by GovInfoNow · govinfonow.com/recall/61981-b-braun-pumps-recall-leakage-risk-in-15-dr-3 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2555-2021

Cite this page

“B. Braun Pumps Recall: Leakage Risk in 15-Dr 3-CareSite Sets.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61981-b-braun-pumps-recall-leakage-risk-in-15-dr-3. Based on FDA recall #Z-2555-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2555-2021%22&limit=1).

B. Braun Medical, Inc. recalled pump sets for use with Outlook Safety Infusion System and Horizon NXT Pump due to leakage risks that could cause medication delays or bloodstream infections, according to the FDA on Aug. 10, 2021.

How to tell if you have it

Brand: B. Braun
Product: PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use
Lot Codes: 0061756804, 0061757753, 0061777804
DI: 04046955137015
Units affected: 13,320

The hazard

The pump sets may leak within the cassette portion, potentially causing delays in medication administration, under-delivery, incomplete dosing, and bloodstream infections.

Context

GovInfoNow's records show B. Braun Medical has issued 66 other recalls since Oct. 15, 2013. Other recent recalls of similar products include a B. Braun Medical 100mL Sodium Chloride Injection Recall (Aug. 19, 2026) and a B. Braun Medical Lactated Ringer's Injection Recall (Aug. 12, 2026). Other recent recalls of similar products include a Boston Scientific Intera 3000 Hepatic Artery Pump Recall (May 11, 2026) and an ICU Medical CADD Yellow Medication Cassette Reservoir Recall (Aug. 20, 2026).

How to tell if you have this one

Check for the model 'PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use' with lot codes 0061756804 to 0061777804. These were sold with Outlook Safety Infusion System or Horizon NXT Pump.

Brand
B. Braun
Category
Medical device

FDA recall event · 17 products

All 17 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
Terminated
Distribution
Worldwide distribution - US Nationwide distribution and the country of Canada.

Recall number	Product, codes & lots	Quantity
Z-2544-2021	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	978,876 units
Z-2545-2021	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	585,576 units
Z-2546-2021	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	44,866 units
Z-2547-2021	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	1,960 units
Z-2548-2021	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	55,584 units
Z-2549-2021	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	940 units
Z-2550-2021	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	200 units
Z-2551-2021	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	12,000 units
Z-2552-2021	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	12,216 units
Z-2553-2021	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	1,752 units
Z-2554-2021	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	504 units
Z-2555-2021	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	13,320 units
Z-2556-2021	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	7,248 units
Z-2557-2021	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	768 units
Z-2558-2021	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	504 units
Z-2559-2021	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	1,080 units
Z-2560-2021	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	336 units

Based on the official FDA remedy

What to do — step by step

Check Pump Set Details
Identify the lot code on the pump set packaging to confirm if it's affected (0061756804 to 0061777804).
Contact Manufacturer
Reach out to B. Braun Medical for guidance on next steps if you have the recalled pump set.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution 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 terminated this recall 3.1 years after the firm started it.

Aug 10, 2021Firm started the recall
Sep 24, 2021FDA classified it Class II
Oct 6, 2021Published in FDA’s Enforcement Report
Sep 16, 2024FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/61981-b-braun-pumps-recall-leakage-risk-in-15-dr-3">B. Braun Pumps Recall: Leakage Risk in 15-Dr 3-CareSite Sets (GovInfoNow)</a>

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-2555-2021 (August 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2555-2021 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.