Class 2 Device Recall Medtronic Scalp Clip Gun Kit

• Date Initiated by Firm: May 03, 2018
• Create Date: September 21, 2018
• Recall Status: Terminated on August 30, 2022
• Recall Number: Z-3212-2018
• Recall Event ID: 80657
• 510(K)Number: K050044
• Product Classification: Clip, scalp - Product Code HBO
• Product: Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use
• Code Information: Product Number/CFN: CM8902 UDI-Device Identifier (GTIN/UPN): 20643169647200 Lot Numbers: 54984; 57188; 59558; 66312; and 67988
• Recalling Firm/ Manufacturer: Medtronic Neurosurgery; 125 Cremona Dr; Goleta CA 93117-3083
• For Additional Information Contact: Kirk Kauffman; 805-571-8400
• Manufacturer Reason for Recall: The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not use if package has been previously opened or damaged , it is possible that the seal breach may go undetected by the user's naked eye.
• FDA Determined Cause: Under Investigation by firm
• Action: Consignee Notification URGENT: MEDICAL DEVICE RECALL has been sent to US customers on 03-May-2018. For foreign customers, the Consignee Notification is in process. The Consignee letter informs customers of the situation and the required course of action which includes: 1. Cease use of the listed product 2. Account for number of product units used or discarded and return any units by completing the attached individualized Customer Confirmation form provided. Please follow the instructions described in the Customer Confirmation form. 3. Clinicians and their Patients who may have received the listed devices should monitor the patients condition to determine if there are any signs of infection. If this is the case, the patient should seek medical attention immediately to treat the infection. In addition, the Notification Letter should be provided to all those who need to be aware of this matter within your organization or to any organization where the potentially affected products may have been transferred. Fax the Customer Acknowledgement Response Form to Medtronic Neurosurgery at (805) 571-8787 or take a clear picture or scan of signed form and email it to rs.mnsfca@medtronic.com with "Magazine Recall" in the subject line.
• Quantity in Commerce: 2616
• Distribution: Domestic: AL, AZ, AR, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, LA, MD, MI, MN, MS, MO, NB, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY OUS: Australia, Germany, Kenya, Russian Federation, South Africa
• 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 = HBO