—#143622

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.

FDA product code: FCG — Biopsy Needle
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K936194
Affected lot / code info: Part Number: C2016B Lot Numbers: REWL0924, REXA1695, REXB1529, REXC1632

Why it was recalled

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 (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-02-04
Terminated: 2016-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143622. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.