Class 2 Device Recall TruGuide Disposable Coaxial Biopsy Needles

• Date Initiated by Firm: February 04, 2016
• Create Date: October 02, 2018
• Recall Status: Terminated on August 03, 2016
• Recall Number: Z-1396-2016
• Recall Event ID: 73249
• 510(K)Number: K936194
• Product Classification: Biopsy needle kit - Product Code FCG
• Product: Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
• Code Information: Part Number: C2016B Lot Numbers: REWL0924, REXA1695, REXB1529, REXC1632
• Recalling Firm/ Manufacturer: Bard Peripheral Vascular Inc; 1625 W 3rd St; Tempe AZ 85281-2438
• For Additional Information Contact: Raye Seisinger; 800-321-4254
• Manufacturer Reason for Recall: Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: The firm sent a customer notification letter on 02/04/15 to each of the US consignees via FedEx with proof of delivery notification. The firm's notification letter provided the following instructions for completing the required actions: 1. Do not further use the affected product. 2. Check all inventory locations within the institution for affected product code/lot number combination listed in the recall notice. If further distributed any of the product code/lot numbers immediately contact that location, advise them of the recall, forward the instructions and have them return the affected product to BPV. 3. Remove any identified product from shelves. Once the product affected by this recall has been removed from inventory: 5. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that are in stock. It is extremely important that the firm receive this information even if no longer have possession of the recalled product. 6. Please call Recall Coordinator Raye Seisinger at 1-800-321-4254 Option #2 Ext 2501 (M-F 6am to 3pm MST) or email at raye.seisinger@crbard.com. Once all information has been verified, the Recall Coordinator will issue either a Return Authorization (XC) Number or Consignment Recall Number (XH) to facilitate the expedient return of the product. BPV will provide replacement product for the returned product. 7. Fax the Recall and Effectiveness Check Form to BPV at 1-800-994-6772. If cannot FAX the form call the BPV recall coordinator (Raye Seisinger, at 1-800-321-4254 Option #2 Ext 2501) and report the required information verbally. 8. A mailing label is enclosed for convenience to return the affected product. Mark the outside package as "RECALLED PRODUCT" and include the XC or XH number. All products should be returned to the following shipping address: Bard Peripheral Vascular, Inc. 1415 W. 3'd Street Tempe, AZ 85281 9. Please report any new and
• Quantity in Commerce: 2320 units
• Distribution: U.S. distribution to the following; SC, CO, MT, PA, MA, TX, MI, VA OH, CA, GA, WA, MO, KS, TN, IA, FL, NV, PR. Foreign distribution to the following; Canada, Austria, Brazil, China, Cyprus, Holland, France, Spain, Netherlands, Norway, Portugal, UK.
• 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