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Nimbus PainPro Ambulatory Infusion Pumps with software… recallZ-0832-2022 · InfuTronix LLC · initiated Oct 19, 2021

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.

FDA root cause category: Employee error

What the company is doing

An IMPORTANT PRODUCT INFORMATION letter dated 10/19/21 was sent to customers. InfuTronix LLC has recently become aware of an unreleased Version 4 Protocol Library for Duke University Hospital was installed on your Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients. Please ensure that all your potential customers and potential users in your facility are made aware of this notification and the recommended actions. Product Issue Version 4 of the Duke Protocol Library was installed on your infusion pumps in error. Affected Product Details Nimbus PainPro (H) Pump, Model numbers: IT1072, sold as kits IT1075-DUKE-HSP Total number of infusion pumps affected: 3 Lot numbers involved: 2009231440 Instructions 1. Place all units you have in-house on product-hold and stop further distribution 2. Inform your customer to discontinue use of the affected infusion pumps. Product Correction InfuTronix will be contacting you to resolve this issue as quickly as possible. Contact Information Your Account Manager, Vann Griffin, email: [email protected], phone: (919) 606-8339 Or John LaFratta, Vice President of Sales, email: john.lafratta@ nimbuspainpro.com , phone: 315-729-5564. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately.

Recall details

Recall number
Z-0832-2022
Status
Open, Classified
Initiated by the company
Oct 19, 2021
Recalling firm
InfuTronix LLC
Quantity
74 units
Product code
FRN
FDA submissions
K153193
Distribution
US Nationwide distribution in the states of NC and OH.

Product description

Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP

Code information (models, lots, serial numbers)

(UDI): (01)00817170020086; Lot: 2009231440; Serial Numbers: 807483, 807484, 807485, 807486, 807487, 807489, 807490, 807491, 807492, 807493, 807494, 807495, 807496, 807497, 807498, 807499, 807500, 807502, 807651, 807652, 807653, 807507, 807508, 807509, 807510, 807511, 807512, 807513, 807514, 807515, 807516, 807517, 807518, 807519, 807520, 807521, 807522, 807523, 807524, 807525, 807526, 807527, 807528, 807529, 807530, 807531, 807532, 807533, 807534, 807535, 807536, 807537, 807538, 807539, 807540, 807541, 807542, 807543, 807544, 807545, 807546, 807547, 807548, 807549, 807550, 807551, 807552, 807553, 807554, 807654, 807655, 807656, 807657, 807658

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

4 devices cleared under K153193 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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