Bard Peripheral Vascular Inc: Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

Recall number

Z-1396-2016

Recalling firm

Bard Peripheral Vascular Inc

Product

Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

Status

Terminated

Initiated

2016-02-04

Posted

not on file

Terminated

2016-08-03

Reason

Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial.

Root cause

Unknown/Undetermined by firm

Action

The firm sent a customer notification letter on 02/04/15 to each of the US consignees via FedEx with proof of delivery notification. The firm's notification letter provided the following instructions for completing the required actions: 1. Do not further use the affected product. 2. Check all inventory locations within the institution for affected product code/lot number combination listed in the recall notice. If further distributed any of the product code/lot numbers immediately contact that location, advise them of the recall, forward the instructions and have them return the affected product to BPV. 3. Remove any identified product from shelves. Once the product affected by this recall has been removed from inventory: 5. 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. It is extremely important that the firm receive this information even if no longer have possession of the recalled product. 6. Please call Recall Coordinator Raye Seisinger at 1-800-321-4254 Option #2 Ext 2501 (M-F 6am to 3pm MST) or email at raye.seisinger@crbard.com. Once all information has been verified, the Recall Coordinator will issue either a Return Authorization (XC) Number or Consignment Recall Number (XH) to facilitate the expedient return of the product. BPV will provide replacement product for the returned product. 7. Fax the Recall and Effectiveness Check Form to BPV at 1-800-994-6772. If cannot FAX the form call the BPV recall coordinator (Raye Seisinger, at 1-800-321-4254 Option #2 Ext 2501) and report the required information verbally. 8. A mailing label is enclosed for convenience to return the affected product. Mark the outside package as "RECALLED PRODUCT" and include the XC or XH number. All products should be returned to the following shipping address: Bard Peripheral Vascular, Inc. 1415 W. 3'd Street Tempe, AZ 85281 9. Please report any new and

Quantity

2320 units

Distribution

U.S. distribution to the following; SC, CO, MT, PA, MA, TX, MI, VA OH, CA, GA, WA, MO, KS, TN, IA, FL, NV, PR. Foreign distribution to the following; Canada, Austria, Brazil, China, Cyprus, Holland, France, Spain, Netherlands, Norway, Portugal, UK.

Lot, serial or model codes

Part Number: C2016B Lot Numbers: REWL0924, REXA1695, REXB1529, REXC1632

510(k) numbers

["K936194"]

PMA numbers

not on file

Product code

FCG

Firm FEI

2020394

Firm city

Tempe

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy