Z-2055-2019Class II

Nimbus Administration Set, REF HS-004, UDI # 00817170020031

Name: Z-2055-2019 Nimbus Administration Set, REF HS-004, UDI # 00817170020031
Creator: InfuTronix LLC
Published: 2019-05-28
License: https://open.fda.gov/license/

InfuTronix LLC / initiated 2019-05-28 / Terminated / root cause: manufacturing process

FDA source

InfuTronix LLC began a recall of Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a... on 2019-05-28. FDA classified it as Class II and gives the reason as "Potential for tube leakage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2055-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Posted: 2019-07-23
Terminated: 2020-06-22
Recalling firm: InfuTronix LLC
Product: Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
Product code: FRN Pump, Infusion
Reason for recall: Potential for tube leakage
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On May 28, 2019 InfuTronix LLC issued Voluntary Recall notices to their customer via email. On June 10, 2019, InfuTronix LLC issued a second notice to customers via email dated June 4, 2019 which provides more information on the reason for recall. On August 6th, 2019, InfuTronix LLC issued a third Urgent Medical Device Recall notice to customers advising them of an additional lot. Customers are advised to take the following actions: 1) Inspect stock and remove all products listd on the notice. 2) Immediately return them to InfuTronix LLC for replacement. 3) Customers may call the telephone number listed or email for instructions on what to do with the product. 4) Please contact InfuTronix at 508-907-7791 Monday to Friday 9:30 am to 5 pm, EST. 5) Return the completed response form via email to [email protected].
Quantity in commerce: 10,800 units
Distribution: US distribution in the state of MA
Product codes and lots: 1) Lot # 1805002, Exp Date 06/10/2021, 2) Lot # 1712005, Exp Date 12/19/2020, 3) Lot # 1710012, Exp Date 10/22/2020, 4) Lot # 1901003, Exp Date 01/07/2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2055-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2055-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-23

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)