—#135737

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.

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K133948
Affected lot / code info: Product Code: MC1820 Gauge x Lengh: 18g x 20cm Lot Numbers: REYA2017, REYC2853

Why it was recalled

The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.

Root cause (FDA determination)

Process design

Action the firm took

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

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Ste 109, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-04-09
Posted by FDA: 2015-05-06
Terminated: 2015-09-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135737. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.