Stop using nowMedical device recall · FDA · Published September 15, 2022
B. Braun Medical: CARESITE Smallbore Extension Set Recall - Risk of Leakage and Infection
B. Braun Medical recalls 100 units per carton of CARESITE Smallbore Extension Set T-Port 5 in. due to high risk of leakage or detachment at bonded joints, potentially causing infections or life-threatening complications.
The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.
B. Braun Medical is recalling 100 units per carton of CARESITE Smallbore Extension Set T-Port 5 in. because the extension set may leak or detach at the bonded joint during use, leading to possible bloodstream infections or life-threatening situations like air embolism. Read more at govinfonow.com/recall/60054-b-braun-medical-caresite-smallbore-extension-set-recall-risk-of.
“B. Braun Medical: CARESITE Smallbore Extension Set Recall - Risk of Leakage and Infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60054-b-braun-medical-caresite-smallbore-extension-set-recall-risk-of. Based on FDA recall #Z-0092-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0092-2023%22&limit=1).
B. Braun Medical, Inc. recalled CARESITE SMALLBORE EXT SET T-PORT 5 IN. extension sets due to potential leakage or detachment at the bonded joint, according to the FDA on September 15, 2022.
The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.
Context
GovInfoNow's records show B BRAUN MEDICAL INC has 66 other recalls on record since 2013-10-15. Recent brand recalls include a Sodium Chloride Injection recall on 2026-08-19 for particulate matter, a Lactated Ringer's Injection recall on 2026-08-12 for particulate matter, and a Discofix Four Way Stopcock recall on 2026-08-04 for an incorrect expiration date. Other recent recalls of similar products include BD 60-In Extension Sets (2026-06-16), ICU Medical CADD Yellow Medication Cassette Reservoir Recall (2026-08-20), and Medline IV Sets recall (2025-12-31).
How to tell if you have this one
Check for the product code 470114 on the carton. The item is sold in sets of 100 units per carton and includes the A6 Access Device valve for IV fluid and blood flow.
Brand
B. Braun Medical
Category
Medical device
FDA recall event · 3 products
All 3 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
Ongoing
Distribution
Distribution US nationwide, Canada and Saudi Arabia.
Recall number
Product, codes & lots
Z-0090-2023
ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets; UDI-DI (GTIN): 04046964185670 Lots/Expiration Dates 0061627491 31 May 2023 0061637554 31 Jul 2023 0061656218 31 Dec 2023 0061659612 31 Jan 2024 0061662459 31 Jan 2024 0061667312 29 Feb 2024 0061671264 31 Mar 2024 0061712679 31 Dec 2024 0061716017 31 Jan 2025 0061718208 31 Jan 2025 0061719862 31 Jan 2025 0061762008 31 Dec 2025 0061765391 31 Jan 2026 0061791921 31 JUL 2026
Z-0091-2023
Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.; UDI-DI (GTIN): 04046964540943 Lots/Expiration Dates 61705083 31-Oct-22 61705124 31-Oct-22 61706055 31-Oct-22 61714103 31-Dec-22 61719696 31-Jan-23 61732456 31-Mar-23 61736580 31-May-23 61739427 31-May-23 61744671 31-Jul-23 61747367 31-Aug-23 61750206 31-Aug-23 61752658 30-Sep-23 61761422 30-Nov-23 61776447 30-Apr-24 61780880 30-Apr-24 61802320 30-Sep-24 61806067 31-Oct-24 61807459 31-Oct-24 61822282 28-Feb-25
Z-0092-2023
CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.; UDI-DI (GTIN): 04046964298691 Lots/Expiration Dates 61762215 15-Dec-23 61762791 22-Jan-24 61767369 26-Feb-24 61779625 7-Jun-24 61791895 11-Aug-24 61806047 4-Nov-24
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the CARESITE Smallbore Extension Set T-Port 5 in. with product code 470114 as it may leak or detach during use.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution US nationwide, Canada and Saudi Arabia.” 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 published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0092-2023 (September 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0092-2023 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.