Class 2 Device Recall CE17TKPS CONTINUOUS EPIDURAL ANES TRAY

• Date Initiated by Firm: July 20, 2018
• Create Date: October 01, 2018
• Recall Status: Terminated on May 13, 2020
• Recall Number: Z-3370-2018
• Recall Event ID: 80811
• Product Classification: Catheter, conduction, anesthetic - Product Code BSO
• Product: CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233; ; Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.
• Code Information: Batch: 61582595, 61599648, 61605283, 61611124, 61614787
• Recalling Firm/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Blvd; Allentown PA 18109-9512
• For Additional Information Contact: Connie Walker; 610-596-0500
• Manufacturer Reason for Recall: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, B. Braun, sent an "URGENT MEDICAL DEVICE CORRECTION  RECALL NOTIFICATION" letters dated 7/20/18 to its customers. The letters described the product, problem and actions to be taken. The letters instruct customers to do the following: 1. Review this Medical Device Correction Notification in its entirety and ensure that all users of the mentioned products in your organization and other concerned persons are informed about this Medical Device Correction  Recall Notification. If you are a distributor, please forward this recall notification to your customers. 2. For continued safe use of the Perifix Catheter Connector as part, review and follow the instructions described in Attachment 2, Step-by-Step Correction of the Perifix Catheter Connector using Label . 3. For continued safe use of the Perifix Catheter Connector, review and follow the instructions described in Attachment 3, Step-by-Step Correction of the Perifix Catheter Connector using Cloth/Silk Medical Tape . This method can be applied to the Perifix Catheter Connector in Procedural Trays. 4. Utilizing the attached Medical Device Correction  Recall Notification Acknowledgement form, please acknowledge that you have received and reviewed this information. 5. Return the completed Medical Device Correction  Recall Notification Acknowledgement form to B. Braun Medical Inc. Quality Assurance department by faxing to: 610-849-1197 or e-mailing to: PA_QualityAssurance.BBMUS_Service@bbraunusa.com the form within two (2) weeks of receipt of this notice. It is important this form is returned so B. Braun Medical Inc. can meet regulatory requirements of the United States Food and Drug Administration. 6. If you have any affected products as identified in attachment 1 that you choose to return instead of following the continued safe use instructions within Attachment 2 and 3, please identify on the Medical Device Correction  Recall Notification Acknowledgement form that you will be returning t
• Quantity in Commerce: 2400
• Distribution: Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.
• 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.