Class 2 Device Recall Smoothbore breathing system with exhalation port 22 mm

• Date Initiated by Firm: November 11, 2020
• Create Date: December 30, 2020
• Recall Status: Terminated on August 09, 2022
• Recall Number: Z-0753-2021
• Recall Event ID: 86800
• Product Classification: Anesthesia breathing circuit kit (adult & pediatric) - Product Code OFP
• Product: Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
• Code Information: Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283
• FEI Number: 1000120301
• Recalling Firm/ Manufacturer: Intersurgical Inc; 6757 Kinne St; East Syracuse NY 13057-1215
• For Additional Information Contact: Marissa Hovey; 800-828-9633
• Manufacturer Reason for Recall: The device was assembled with the incorrect exhalation port which can cause gas leakage.
• FDA Determined Cause: Process control
• Action: Recall Strategy and Instruction: 1. Immediately discontinue use and quarantine any stock with the product/lot number described above in this recall notification. 2. If you have distributed any of these products, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. 3. Complete the Customer Product Recall Acknowledgement Form a. Return the completed form via email to Intersurgical Inc. at mhovey@intersurgicalinc.com. b. The subject line should contain Intersurgical Recall: Company name c. Please note: If you do not have the recalled product in stock, please check the appropriate box on the Customer Product Recall Acknowledgement Form. 4. Once we receive your Customer Product Recall Acknowledgement Form, Intersurgical Customer Support will issue a Return Goods Authorization (RGA) Number for the amount of product you have on-hand to return. a. Intersurgical will credit your account when the product is received. Intersurgical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact Customer Support at 800-828-9633 or email at support@intersurgicalinc.com. Distribution: Distribution began 09/02/2020 Distributed: 200 pieces
• Quantity in Commerce: 200 devices
• Distribution: All of the devices were shipped to the same distributor (McKesson).
• 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.