Class 2 Device Recall Bard Monopty Disposable Core Biopsy Instruments and Kits

• Date Initiated by Firm: March 17, 2015
• Date Posted: April 14, 2015
• Recall Status: Terminated on August 03, 2015
• Recall Number: Z-1447-2015
• Recall Event ID: 70733
• 510(K)Number: K133948
• Product Classification: Instrument, biopsy - Product Code KNW
• Product: Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410.; ; The BARD MONOPTY Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow=20 gauge, Pink=18 gauge, Purple=16 gauge, Green=14 gauge, and Light Blue=12 gauge. (Only the 14 gauge size has been reported to be affected by this issue). The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
• Code Information: Lot Number: REYK1575, REYL0126, REYI1423, REYI2144, REYI2147, REYI2257, REYI2259, REYJ0186, REYJ0652, REYJ1221, REYJ2078, REYK0399, REYK0794, REYK1112, REYK1573, REYL0042, REYL0523, REYL1225.
• Recalling Firm/ Manufacturer: Bard Peripheral Vascular Inc; 1625 W 3rd St Ste 109; Tempe AZ 85281-2438
• For Additional Information Contact: Raye Seisinger; 800-321-4254 Ext. 2501
• Manufacturer Reason for Recall: Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm, Bard Peripheral Vascular, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 3/17/15 to customers. The letter informs customers of the problems identified and the actions to be taken. The customers were instructed to do the following: Do not use or further distribute any affected product; check all inventory locations within your institution; if you have further distributed any of the product, advise them of the recall and have them return the affected product to BPV; remove any idenfied product from your shelves; and complete and return the attached Recall and Effectiveness Check Form to BPV by fax at (800) 994-6772, if you cannot FAX the form, call the BPV telephone number provided on the form and report the required information verbally. BPV will provide replacement product for your returned product. Customers are instructed to call BPV's Recall Coordinator at 1-800-321-4254 Option #2 Ext 2988 (M-F 7am to 4pm MST) or email at HUrandy.hopkins@crbard.comUH.
• Quantity in Commerce: 29,342 units
• Distribution: Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan.
• 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 = KNW and Original Applicant = BARD PERIPHERAL VASCULAR, INC.