Use cautionMedical device recall · FDA · Published May 1, 2019
B. Braun Infusion Pump Set Recall: Leaks or Disconnects at Y-Site
B. Braun recalls specific infusion pump sets that may leak or disconnect at the Y-site joint, causing potential injury. Affected units have catalog number 363:032 and lot number 0061641410.
“B. Braun Infusion Pump Set Recall: Leaks or Disconnects at Y-Site.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67979-b-braun-infusion-pump-set-recall-leaks-or-disconnects-at. Based on FDA recall #Z-2489-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2489-2019%22&limit=1).
B. Braun Medical, Inc. recalled B.Braun Infusomat Space Volumetric Infusion Pump Administration Set catalog number 363032 due to a potential leak or disconnection hazard, the FDA said on May 1, 2019.
How to tell if you have it
Brand: B. Braun
Product: B.Braun Infusomat Space Volumetric Infusion Pump Administration Set
Catalog Number: 363032
Lot Number: 0061641410
Units affected: 2580
The hazard
The recall addresses the potential for the infusion pump administration set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site), according to the FDA.
Context
GovInfoNow's records show B BRAUN MEDICAL INC has 66 other recalls on record since Oct. 15, 2013. Other recent recalls of similar products include Fresenius Kabi LVP-0004 Infusion Pump Recall (Feb. 4, 2026), Medline Kits with B. Braun IV Sets Recalled for Check Valve Stuck Issue (Nov. 26, 2025), and Becton Dickinson Swan-Ganz Jr Catheter Recall (April 8, 2026).
How to tell if you have this one
Check for the catalog number 363032 and lot number 0061641410 on the product packaging. The product is sold by B. Braun Medical, Inc.
Brand
B. Braun
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Leaks or Disconnects
Inspect the tubing at the Y-site joint for leaks or signs of disconnection.
Where it went and when
Where it was distributed
Distributed in Texas, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distribution to US state of TX, and Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-2489-2019 (May 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2489-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.