Class 2 Device Recall Nimbus PainPro Ambulatory Infusion Pumps

• Date Initiated by Firm: October 19, 2021
• Create Date: March 29, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0832-2022
• Recall Event ID: 89711
• 510(K)Number: K153193
• Product Classification: Pump, infusion - Product Code FRN
• Product: 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: (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
• Recalling Firm/ Manufacturer: InfuTronix LLC; 177 Pine St; Natick MA 01760-1331
• For Additional Information Contact: Lorraine Hanley; 508-315-8320
• Manufacturer Reason for Recall: 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 Determined Cause: Employee error
• Action: 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: vann.griffin@nimbuspainpro.com, 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.
• Quantity in Commerce: 74 units
• Distribution: US Nationwide distribution in the states of NC and OH.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN