Class 2 Device Recall 20IN (50.8CM) BRAIDED INJ LINE

• Date Initiated by Firm: November 10, 2023
• Date Posted: January 17, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0745-2024
• Recall Event ID: 93506
• 510(K)Number: K954970
• Product Classification: Transducer, blood-pressure, extravascular - Product Code DRS
• Product: 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
• Code Information: Lot Number: 4398428 4404690
• Recalling Firm/ Manufacturer: Smiths Medical Asd Inc; 6250 Shier Rings Rd; Dublin OH 43016-1270
• For Additional Information Contact: Customer Service; 800-258-5361
• Manufacturer Reason for Recall: There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
• FDA Determined Cause: Nonconforming Material/Component
• Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 11/10/23 was sent to customers. Required Actions for Users: 1. Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2. Inform potential users of the product in your organization of this notification and complete and return the attached response form to smithsmedical7166@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification, even if you do not have the affected product and/or it has already been used. 3. If you have distributed the product further, immediately notify your accounts that receive the product identified in the Affected Items / Table 1 sections of this notification and ask them to contact Sedgwick at 1-855-215-5142 (MF, 8am-5pm ET) to obtain a response form. 4. If the product has not already been used, please return affected lots to Smiths Medical and Smiths Medical will offer replacement units. Global Complaint Management globalcomplaints@icumed.com 1-(866)-216-8806 Customer Service 1-(800)-258-5361
• Quantity in Commerce: 31,685 total
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE.
• 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 = DRS