Class 1 Device Recall Cook Transseptal Needle

• Date Initiated by Firm: February 01, 2019
• Date Posted: March 13, 2019
• Recall Status: Terminated on June 30, 2020
• Recall Number: Z-0979-2019
• Recall Event ID: 82124
• Product Classification: Trocar - Product Code DRC
• Product: Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
• Code Information: Lot 8833687
• Recalling Firm/ Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: 812-339-2235
• Manufacturer Reason for Recall: The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
• FDA Determined Cause: Process control
• Action: Urgent Medical Device Recall notification letters were sent to customers on 2/1/19. Action to take 1. Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Unaffected products that are returned will not be credited. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to CustomerRelationsNA@CookMedical.com.
• Quantity in Commerce: 100
• Distribution: US nationwide and Canada. US distribution to the following states: AZ, FL, IL, IN, KS, MA, MI, MO, PA, SC, TN, and WA. The products were distributed to the following foreign countries: Canada.
• 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.