Recall Z-2469-2019

Reason for recall

The filter capacity is not achieved due to damage of the filter membrane.

FDA-determined cause: Under Investigation by firm

Action taken

1. Review the Device Recall Notification entirety and ensure that all users in your organization 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 consumer level. 2. Determine your current inventory of the affected lots within your facility. 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 these affected products as identified in the Product Removal Acknowledgement form that was submitted to BBMI Quality Assurance Department, a BBMI 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 Clinical and Technical Support Department at 1-800-854-6851