Class 2 Device Recall Plus 30 Priority Pack

• Date Initiated by Firm: March 11, 2022
• Create Date: April 13, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0925-2022
• Recall Event ID: 89760
• 510(K)Number: K962495
• Product Classification: Syringe, balloon inflation - Product Code MAV
• Product: Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01); ; Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)
• Code Information: Part Numbers: 1000185 Device Identifier-GTIN: 8717648013607 Lot Numbers: 60317532 60323314 60329935 60323313 60326601 Part Numbers: 1000185-115 Device Identifier-GTIN: 08717648015267 Lot Numbers: 60316763 60323315
• Recalling Firm/ Manufacturer: Abbott Vascular; 26531 Ynez Rd; Temecula CA 92591-4630
• For Additional Information Contact: Alicia Swanson; 408-845-3427
• Manufacturer Reason for Recall: Due to an increase in complaint trend for leaks and intermittent/loose connections.
• FDA Determined Cause: Component change control
• Action: On 03/11/2022, the firm sent an "URGENT FIELD SAFETY NOTICE/DEVICE RECALL" Letter via visit, email or mail, to customers informing them that specific lots of 20/30 INDEFLATOR, INDEFLATOR Plus 30 and associated Priority Packs my exhibit leaks and/or a loose connection at the rotating luer assembly or stopcock connection, which could lead to air ingress under vacuum. Customers are instructed to: 1)Immediately stop using the devices from the affected lots 2) Review their inventory, complete and return the provided Effectiveness Check Form 3) Return all unused affected devices to the Recalling Firm 4) Share the Recall Notification with relevant personnel in their organization 5) if the affected products have been further distributed/transferred, notify those customers 6) Report any occurrence of product performance issues or patient adverse events to the Recalling Firm at 800-227-9902 The Recalling Firm: -Has immediately stop shipping devices from affected lots -Conducting an investigation to determine/confirm that there are not other affected products or lots in distribution -Implementing appropriate corrective actions to ensure product performance -Will work to replace inventory when available For questions or assistance contact the local representative or customer service department at 800-227-9902
• Quantity in Commerce: 7 lots
• Distribution: U.S Nationwide Distribution.: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, VA, WA, and WI. O.U.S.: United Arab Emirates, France, Pakistan, Argentina, United Kingdom, Portugal, Australia, Greece, R¿union, Belgium, Guam, Romania, Brazil, Indonesia, Russian Federation, Bahamas, Israel, Saudi Arabia, Canada, India, Singapore, Switzerland, Italy, Slovakia, Chile, Jamaica, Thailand, China, Japan, Taiwan Republic of China, Colombia, Korea (South), Costa Rica, Luxembourg, Uruguay, Czech Republic, Mexico, Vietnam, Germany, Netherlands, South Africa, Dominican Republic, New Zealand, Spain, and Panama
• 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 = MAV and Original Applicant = ADVANCED CARDIOVASCULAR SYSTEMS, INC.