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U.S. Department of Health and Human Services

Class 2 Device Recall Steripath Gen2, Luer, BD

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  Class 2 Device Recall Steripath Gen2, Luer, BD see related information
Date Initiated by Firm August 02, 2021
Create Date August 31, 2021
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = Magnolia Medical Technologies, Inc.
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