Class 2 Device Recall Bard Mission Disposable Core Biopsy Instrument Kit

• Date Initiated by Firm: February 28, 2023
• Date Posted: March 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1260-2023
• Recall Event ID: 91638
• 510(K)Number: K171953
• Product Classification: Instrument, biopsy - Product Code KNW
• Product: Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
• Code Information: REF/UDI-DI/Lot(Expiration Date): 1610MSK/00801741142567/1445630(11/28/2024), 1449980(12/28/2024), 1451134(1/28/2025); 1816MSK/00801741097065/1447510(12/28/2024), 1447511(12/28/2024), 1447512(12/28/2024), 1447513(12/28/2024), 1448118(12/28/2024), 1448119(12/28/2024), 1448120(12/28/2024), 1448121(12/28/2024), 1448743(12/28/2024), 1450413(12/28/2024), 1450414(12/28/2024), 1451075(1/28/2025), 1451076(1/28/2025), 1451621(1/28/2025), 1451622(1/28/2025), 1451625(1/28/2025), 1451626(1/28/2025), 1453516(1/28/2025), 1453517(1/28/2025), 1454295(1/28/2025), 1456850(2/28/2025), 1456856(2/28/2025), 1457030(2/28/2025)
• Recalling Firm/ Manufacturer: Bard Peripheral Vascular Inc; 1625 W 3rd St Bldg 1; Tempe AZ 85281-2438
• For Additional Information Contact: 480-303-2602
• Manufacturer Reason for Recall: The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility.
• FDA Determined Cause: Mixed-up of materials/components
• Action: On 2/28/23, "URGENT MEDICAL DEVICE RECALL" notices were mailed and emailed to customers and distributors who were told to take the following actions: 1) Discontinue use of and Dispose of all affected product remaining in your possession in accordance with your local facility's process. 2) Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. 3) If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution. 4) Complete and return the attached Customer Response Form and email to: BDRC3@bd.com The recalling firm will issue replacements, as available, or credit. In addition, distributors were asked to do the following: Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification. Customers/distributors who have questions can contact the North American Regional Complaint Center at 1-844-8BD- LIFE (1-844-823-5433), Say Recall when prompted, M-F 8am - 5pm CT
• Quantity in Commerce: 38,635
• Distribution: Worldwide Distribution: US (Nationwide) includes states of: FL, MD, OH, CO, PA, TX, NC, CA, ME, MO, NV, MI, IL, NY, VA, AZ, NH, LA, WI, KY, MA, WA, CT, SD, OK, DC, IA, AR, GA, NE, NM, IN, NJ, MN, PR, AL, AK, SC, KS, OR, ID, VT, MT, WV, ND, TN, MS, HI, WY, RI and OUS countries of: Canada, Korea, Thailand and Taiwan. OUS: AR, AU, BE, CA, CN, CO, HK, IN, JP, KR, TH, TW
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KNW