Class 2 Device Recall McKesson

• Date Initiated by Firm: February 09, 2021
• Create Date: March 15, 2021
• Recall Status: Terminated on April 09, 2024
• Recall Number: Z-1251-2021
• Recall Event ID: 87313
• Product Classification: Needle, hypodermic, single lumen - Product Code FMI
• Product: McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.; ; Product Code: 26558
• Code Information: Lot Code: 028603
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 15 Hampshire St Bldg 5; Mansfield MA 02048-1113
• Manufacturer Reason for Recall: Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
• FDA Determined Cause: Equipment maintenance
• Action: Cardinal Health issued Urgent Medical Device Recall letter on 2/9/21via overnight mail. Letter states reason for recall, health risk and action to take: 1. INSPECT your inventory for the affected product code and lot number (see Attachment A for examples). 2. SEGREGATE and QUARANTINE all on-hand affected product. 3. PLEASE RETURN the enclosed acknowledgment form via facsimile (614-652-9648) or email (GMB-FieldCorrectiveAction@cardinalhealth.com) and indicate the product code, lot and quantity of product youve quarantined. Please respond regardless of whether or not you have affected product. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday  Friday between 8:00am - 5:00pm EST: Hospital800-964-5227 Federal Government800-444-1166 Distributor800-635-6021 All other customers888-444-54401. 6. Customers that did not receive product directly from Cardinal Health should return product through the location where they purchased it. Contact Cardinal Health at 800-292-9332.
• Quantity in Commerce: 108,000 units
• Distribution: Worldwide distribution - US Nationwide distribution and the countries of AE, Japan.
• 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.