Lower riskMedical device recall · FDA · Published May 28, 2019
InfuTronix Nimbus Administration Set Recall: Potential Tube Leakage Risk
InfuTronix recalls Nimbus Administration Sets (REF HS-004) with specific lot numbers due to potential tube leakage during fluid administration. Affected units may cause medication or fluid leaks.
“InfuTronix Nimbus Administration Set Recall: Potential Tube Leakage Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67863-infutronix-nimbus-administration-set-recall-potential-tube-leakage-risk. Based on FDA recall #Z-2055-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2055-2019%22&limit=1).
The FDA announced on May 28, 2019, that InfuTronix LLC voluntarily recalled Nimbus Administration Sets due to potential tube leakage. The agency issued recall number Z-2055-2019 for the Class II device distributed in Massachusetts.
How to tell if you have it
Brand: InfuTronix
Product: Nimbus Administration Set
REF: HS-004
UDI: # 00817170020031
Lot # 1805002, Exp Date 06/10/2021
Lot # 1712005, Exp Date 12/19/2020
Lot # 1710012, Exp Date 10/22/2020
Lot # 1901003, Exp Date 01/07/2022
Quantity: 10,800 units
The hazard
The recall addresses the potential for tube leakage in the Nimbus Administration Set. The device is used to administer fluids or medication from a container to a patient through a needle or catheter.
Context
GovInfoNow's records show InfuTronix LLC has conducted two other recalls since October 19, 2021. On February 21, 2024, the company recalled Nimbus Infusion Pumps due to battery and system failure risks. Other recent recalls of similar products include B Braun ULTRASITE IV Sets Recall (October 29, 2025), B Braun IV Burette Set Recall (October 29, 2025), and B Braun IV Sets Recall (October 29, 2025).
How to tell if you have this one
Check the lot number on the product label. Affected units include specific lots: 1805002 (expiring 06/10/2021), 1712005 (expiring 12/19/2020), 1710012 (expiring 10/22/2020), and 1901003 (expiring 01/07/2022).
Brand
InfuTronix
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Identify the lot number on the product label to determine if it is one of the affected lots listed in the recall.
Where it went and when
Where it was distributed
Distributed in Massachusetts.
Listed by the agency
Not listed
FDA distribution: “US distribution in the state of MA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Massachusetts.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
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-2055-2019 (May 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2055-2019 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.