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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmApril 11, 2023
Date PostedMay 05, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1564-2023
Recall Event ID 91838
510(K)NumberK171953 
Product Classification Instrument, biopsy - Product Code KNW
ProductBard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Code Information REF/UDI-DI/Lot (Expiration Date): 2010MSK/00801741097089/0001445946(11/28/2024), 2016MSK/00801741097096/1458844(02/28/2025)
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		Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionOn 04/11/23 recall notices were distributed to customers who were asked to do the following: 1. Discontinue use and dispose of affected product. 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 or replacement product. 4. Complete and return the Customer Response Form to BRDC31@bd.com 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. If you require further assistance please contact: North American Regional Complaint Center, Phone: 1-844-8BD- LIFE (1-844-823-5433), say "Recall" when prompted, M-F 8am - 5pm CT, or email: productcomplaints@bd.com
Quantity in Commerce4,120
DistributionUS Nationwide Distribution: PR, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY . OUS: BE, CA, AU
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KNW
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