Class 2 Device Recall Infusomat Space Volumetric Pump Administration Set

• Date Initiated by Firm: June 25, 2021
• Create Date: July 23, 2021
• Recall Status: Terminated on October 16, 2023
• Recall Number: Z-2137-2021
• Recall Event ID: 88198
• 510(K)Number: K142036
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Infusomat Space Volumetric Pump Administration Set, Product Code 490100
• Code Information: Lot Number: 0061761278
• Recalling Firm/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Blvd; Allentown PA 18109-9512
• For Additional Information Contact: Quality Assurance; 610-849-1197
• Manufacturer Reason for Recall: There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.
• FDA Determined Cause: Process control
• Action: Urgent Medical Device Recall Notification letters dated 6/25/21 were sent to customers. Actions Required By BBMI Customer/User: 1. Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the customer level. 2. Determine your current inventory of the affected lot within your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached "Product Removal Acknowledgement," form, record the total number of individual units (within partial cases) and the number of full-unopened cases. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed "Product Removal Acknowledgement" form to B. Braun Medical Inc. Quality Assurance department by faxing the form to ( 610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. If you have any full cases, partial cases or unused individual pieces of this affected product as identified in the "Product Removal Acknowledgement" form that was submitted to BBMI Quality Assurance Department, a BBMl Customer Support Representative will contact you to provide instructions for handling the affected product and arrange for return to BBMI. This may include credit or replacement product. Should you identify product where this issue has occurred, please report the event promptly to BBMI by contacting our Medical Affairs Department at 1-800-854-6851.
• Quantity in Commerce: 36,144 units
• Distribution: Affected products were distributed to the following US states: CA, MI, OR, and UT.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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