Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall BARD MAXCORE Disposable Core Biopsy Instrument

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall BARD MAXCORE Disposable Core Biopsy Instrument see related information
Date Initiated by Firm April 09, 2015
Date Posted May 06, 2015
Recall Status1 Terminated 3 on September 25, 2015
Recall Number Z-1586-2015
Recall Event ID 70952
510(K)Number K133948  
Product Classification Instrument, biopsy - Product Code KNW
Product BARD MAX-CORE Disposable Core Biopsy Instrument

Gauge x Length
18g x 20cm

The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color-coded according to the various gauge sizes e.g., yellow=20 gauge, pink=18 gauge, purple=16 gauge, and green=14 gauge.
Code Information Product Code: MC1820 Gauge x Lengh: 18g x 20cm Lot Numbers: REYA2017, REYC2853
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Ste 109
Tempe AZ 85281-2438
For Additional Information Contact
480-894-9515
Manufacturer Reason
for Recall		 The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.
FDA Determined
Cause 2		 Process design
Action Bard sent an Urgent Medical Device Recall Notification letter dated April 9, 2015 to their customers. The firm's letter provided customers with the following instructions: -Do not use or further distribute any affected product. -Check all inventory locations within the institution for Bard¿ Max-Core Disposable Core Biopsy Instruments for the recalled product code/lot number combination. -If further distributed any of the product code/lot numbers listed, please immediately contact that location, advise them of the recall and have them return the affected product to BVD address listed. -Remove any identified product from the shelves. -If used the affected product, complete, and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Report any new and/or previously unreported adverse events associated with this recall to the US Food and Drug Administration's ("FDA") MedWatch Program by phone at 1-800-FDA-1088; by fax at 1-800- FDA-0178; by mail to MedWatch. Food and Drug Administration. 5600 Fishers Lane. Rockville. MD 20857- 9787: or on line at http://wwvdda.gov/medwatch/report.htm. Once the product affected by this recall has been removed from inventory: -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. -Call the firm's Recall Coordinator Regan Gealy at 1-770-784-6471 or email at Regan.Gealy@crbard.com. The Recall Coordinator will issue either a Return Authorization (RCL) Number or Consignment Recall Number (CRC) to facilitate the expedient return of the product. -Fax the Recall and Effectiveness Check Form back to at 1-770-784-6469. -BPV will provide replacement product for the returned product. A mailing label is going to be enclosed to return the affected product. Mark the outside package as "RECALLED PRODUCT" and include the RCL or CRC number. All products should be returned to the follo
Quantity in Commerce 7,995 units
Distribution Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV and the countries of: France, Mexico, Netherlands, Panama, United Kingdom, Switzerland, Spain, Poland, Norway, Iceland, Italy, Greece, Finland, Belgium, Germany, Austria, China, Taiwan, Singapore, Korea, Australia, and Japan.
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.
-
-