Class 2 Device Recall Bard TruGuide Disposable Coaxial Biopsy Needle

• Date Initiated by Firm: July 06, 2016
• Date Posted: August 16, 2016
• Recall Status: Terminated on November 17, 2016
• Recall Number: Z-2547-2016
• Recall Event ID: 74663
• 510(K)Number: K936194
• Product Classification: Biopsy needle - Product Code FCG
• Product: Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B 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: Lot Number: REZK0479
• Recalling Firm/ Manufacturer: Bard Peripheral Vascular Inc; 1625 W 3rd St; Tempe AZ 85281-2438
• For Additional Information Contact: 800-321-4254
• Manufacturer Reason for Recall: May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.
• FDA Determined Cause: Packaging
• Action: Bard Peripheral Vascular (BVP) sent an Urgent Medical Device Recall Notification letter dated July 6, 2016 to all affected customers via FedEx with proof of delivery notification.. The letter identified the product, the problem, and the action to be taken by the customer. The notification provided customers the following instructions: 1. Do not use or further distribute any affected product. 2. Check all inventory locations within your institution for affected product code I lot number combination listed in the recall notice. If you have further distributed any of the product code I lot numbers, please immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to BPV. 3. Please remove any identified product from shelves. 4. If used the affected product, complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by 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 in stock even if no longer have possession of the recalled product. 6. Call the firm's 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 a Return Authorization (XC) Number or Consignment Recall Number (XH) to facilitate the expedient return of the product. BPV will provide a credit for your returned product. 7. Fax the Recall and Effectiveness Check Form to BPV at 1-800-994-6772. If cannot FAX the form, please call the BPV recall coordinator at 1-800-321-4254 Option #2 Ext 2501) and report the required information verbally. 8. A mailing label is enclosed to return the affected product. Please mark the outside package as "RECALLED PRODUCT" and i
• Quantity in Commerce: 1250 units
• Distribution: Nationwide Distribution to the following; CA, LA, VA, IA, AR, SC, PA, MA, IL, MO. Foreign distribution to the following; Canada, Belgium, Australia, Taiwan, China, Argentina.
• 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