Class 2 Device Recall The Steripath Gen2 Blood Collection System

• Date Initiated by Firm: November 02, 2021
• Create Date: December 01, 2021
• Recall Status: Terminated on May 08, 2023
• Recall Number: Z-0318-2022
• Recall Event ID: 88919
• 510(K)Number: K192247
• Product Classification: Tubes, vials, systems, serum separators, blood collection - Product Code JKA
• Product: The Steripath Gen2 Blood Collection System; ; Model Number/Description; 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck; 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck; 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck; 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck
• Code Information: Model Number/Part Number/Description: 2700-21-EN/P00157-001/Steripath Gen2 Blood Collection System - 21G, Wide Neck UDI Sales Pack: 10858366007013 UDI Sterile Pack: 00858366007016 Lot Numbers: 9447412 9447043 9446903 9447120 9446991 9447413 2700-23-EN/P00158-001/Steripath Gen2 Blood Collection System - 23G, Wide Neck UDI Sales Pack: 10858366007020 UDI Sterile Pack: 00858366007023 Lot Numbers: 9446807 9447124 5005432 9446708 9447121 27BD-21-EN/P00166-000/Steripath Gen2 Blood Collection System - 21G, Long Neck UDI Sales Pack: 10858366007037 UDI Sterile Pack: 00858366007030 Lot Numbers: 5005328 9446696 9446547 9446994 27BD-23-EN/P00167-000/Steripath Gen2 Blood Collection System - 23G, Long Neck UDI Sales Pack: 10858366007044 UDI Sterile Pack: 00858366007047 Lot Numbers: 9447122
• Recalling Firm/ Manufacturer: Magnolia Medical Technologies, Inc.; 200 W Mercer St Ste 500; Seattle WA 98119-5908
• For Additional Information Contact: Kristine Dela Vega; 415-969-8183
• Manufacturer Reason for Recall: Due to an uptick of complaints associated with premature needle retraction of blood collection system.
• FDA Determined Cause: Process control
• Action: On 11/02/2021, the Recalling Firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter to customers via email informing them that the firm has received a number of product complaints associated with its blood collecting systems where the retractable feature of the butterfly needles may prematurely activate. The product complaints have been associated with retractable feature being activated within the product packaging. Customers are instructed to: -Determine the quantity of the affected products remaining at their facility and communicated this to the Recalling Firm's Sales or Clinical team members. -The Recalling Firm will replace any of the affected products at no cost to the customer. -Notify all their staff of the recall and if the affected products have been further distributed, to contact/notify those customers/organization of this recall.
• Quantity in Commerce: 137,200 devices
• Distribution: U.S. Nationwide distribution in the states of MD, WV, DE, VA, DC, IN, MI, MA, SC, NY, IL, TX, AL, OK, GA, NE, FL, MO, CA, CO, NM, AR, WY, KS, PA, WA, MT, and AZ.
• 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.

• 510(K) Database: 510(K)s with Product Code = JKA and Original Applicant = Magnolia Medical Technologies, Inc.