Class 2 Device Recall Steripath Gen2, Luer, BD

• Date Initiated by Firm: August 02, 2021
• Create Date: August 31, 2021
• Recall Status: Terminated on February 22, 2023
• Recall Number: Z-2393-2021
• Recall Event ID: 88338
• 510(K)Number: K192247
• Product Classification: Tubes, vials, systems, serum separators, blood collection - Product Code JKA
• Product: Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer Blood Collection or Urine Collection Tubes.
• Code Information: Catalog #: 27BD-EN, Part #: P00165-000 Lot #9448037
• 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: Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).
• FDA Determined Cause: Labeling Change Control
• Action: On or about 08/02/2021, the firm hand delivered via its Clinical Team an "URGENT: MEDICAL DEVICE RECALL" Notification letter to customers informing them that a specific lot number of transfer adapters was shipped with the incorrect Instructions for Use. Customers are instructed to work with the Recalling Firm's Clinical Team member in identifying the affected products so that replacement Instructions for Use can be provided at no cost. Customers are also instructed to complete a Customer Acknowledgement Form, to record the quantity of affected products each customer has in their inventory and return to their local Recalling Firm's Clinical Team member, or directly to the Recalling Firm. For questions or assistance, contact Customer Service and Sales at 415-969-8183 or email kristine.delavega@magnolia-medical.com
• Quantity in Commerce: 9,400 units
• Distribution: U.S. Nationwide distribution i the states of AL, CO, FL, GA, IL, IN, MD, MI, NE, NY, PA, SC, TX, VA, WV, and WY. O.U.S.: N/A
• 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