Z-1586-2015Class II

BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core...

Name: Z-1586-2015 BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core...
Creator: Bard Peripheral Vascular Inc
Published: 2015-04-09
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2015-04-09 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of 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... on 2015-04-09. FDA classified it as Class II and gives the reason as "The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1586-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-09
Posted: 2015-05-06
Terminated: 2015-09-25
Recalling firm: Bard Peripheral Vascular Inc
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.
Product code: KNW Instrument, Biopsy
Reason for recall: The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. 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.
Product codes and lots: Product Code: MC1820 Gauge x Lengh: 18g x 20cm Lot Numbers: REYA2017, REYC2853

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1586-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1586-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-06

Product code KNW

K133948Class IIBard(r) Monopty(r) Disposable Core Biopsy Instrument, Bard(r) Max-Core(r) Disposable Core InstrumentBard Peripheral Vascular, Inc. / cleared 2014-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)