Class 2 Device Recall Covidien

• Date Initiated by Firm: February 08, 2017
• Date Posted: February 28, 2017
• Recall Status: Terminated on July 18, 2019
• Recall Number: Z-1476-2017
• Recall Event ID: 76497
• 510(K)Number: K103668
• Product Classification: Biopsy needle - Product Code FCG
• Product: BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
• Code Information: Lot number: B000000167
• Recalling Firm/ Manufacturer: Medtronic; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: 800-448-3644 Ext. 2
• Manufacturer Reason for Recall: Handle may break during use.
• FDA Determined Cause: Nonconforming Material/Component
• Action: A recall was initiated on February 8, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 1856 Corporate Dr. Suite 140 Norcross, GA 30093, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.
• Quantity in Commerce: 1,096 Units (total for all products)
• Distribution: US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
• 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 = FCG