Class 2 Device Recall Extension Set

• Date Initiated by Firm: August 08, 2024
• Date Posted: September 13, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3144-2024
• Recall Event ID: 95153
• 510(K)Number: K022895 K111016 K943770
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
• Code Information: Model No 472036; UDI-DI 04046964184659; Lots 0061898815, 0061905158, 00VL872690, 00VL882317 and 00VL882319
• Recalling Firm/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Blvd; Allentown PA 18109-9512
• For Additional Information Contact: Allison Longenhagen; 001-484-2408373
• Manufacturer Reason for Recall: Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.
• FDA Determined Cause: Process change control
• Action: An URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated 8/6/24 was sent to customers. Actions Required by B. Braun Medical Inc. (BBMI) Customer/User: 1. Review the Medical 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 recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is to be extended to the consumer level. 2. Determine your current inventory of the affected items within inventory of your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached "Medical Device Recall Acknowledgement Form", record the total number of individual impacted units. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed "Medical Device Recall Acknowledgement Form" to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to recalls@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we receive your Medical Device Recall Acknowledgement Form, a B. Braun Customer Support representative will contact you with instructions on how to return any impacted cases, including partial cases, in your possession and provide credit and/or replacement of the product based on your individual needs. Adverse reactions or quality problems experienced with this product, or questions about this recall may be reported to BBMl's Postmarket Surveillance Department by calling 1-844-903-6417. They may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Quantity in Commerce: 19050 units
• Distribution: US Nationwide distribution.
• 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 = FPA; 510(K)s with Product Code = FPA; 510(K)s with Product Code = FPA