Nimbus Administration Set, REF HS-004, UDI # 00817170020031 recallZ-2055-2019 · InfuTronix LLC · initiated May 28, 2019
Class II Terminated All recalls posted in July 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from InfuTronix LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for tube leakage
FDA root cause category: Employee error
What the company is doing
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].
Recall details
- Recall number
- Z-2055-2019
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 28, 2019
- Posted by the FDA
- Jul 23, 2019
- Recalling firm
- InfuTronix LLC
- Quantity
- 10,800 units
- Product code
- FRN
- FDA submissions
- K140792, K153193
- Distribution
- US distribution in the state of MA
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
5 devices cleared under K140792, K153193 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Nimbus II PlusInfutronix LLC · Pump, Infusion, Pca1 recall1 death800 reports
- Nimbus II PainPROInfutronix LLC · Pump, Infusion, Pca2 recalls186 reports
- Nimbus II FlexInfutronix LLC · Pump, Infusion, Pca1 recall1 death131 reports
- Nimbus Nimbus II EMSInfutronix LLC · Pump, Infusion, Pca1 recall0 reports
- Nimbus II EpiDInfutronix LLC · Pump, Infusion1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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