—#148135

Product

Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number C1816B 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: Lot Number: REZK0479

Why it was recalled

May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.

Root cause (FDA determination)

Packaging

Action the firm took

Bard Peripheral Vascular (BVP) sent an Urgent Medical Device Recall Notification letter dated July 6, 2016 to all affected customers via FedEx with proof of delivery notification.. The letter identified the product, the problem, and the action to be taken by the customer. The notification provided customers the following instructions: 1. Do not use or further distribute any affected product. 2. Check all inventory locations within your institution for affected product code I lot number combination listed in the recall notice. If you have further distributed any of the product code I lot numbers, please immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to BPV. 3. Please remove any identified product from shelves. 4. If used the affected product, complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by 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 in stock even if no longer have possession of the recalled product. 6. Call the firm's 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 a Return Authorization (XC) Number or Consignment Recall Number (XH) to facilitate the expedient return of the product. BPV will provide a credit for your returned product. 7. Fax the Recall and Effectiveness Check Form to BPV at 1-800-994-6772. If cannot FAX the form, please call the BPV recall coordinator at 1-800-321-4254 Option #2 Ext 2501) and report the required information verbally. 8. A mailing label is enclosed to return the affected product. Please mark the outside package as "RECALLED PRODUCT" and i

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution to the following; CA, LA, VA, IA, AR, SC, PA, MA, IL, MO. Foreign distribution to the following; Canada, Belgium, Australia, Taiwan, China, Argentina.

Timeline

Recall initiated: 2016-07-06
Posted by FDA: 2016-08-16
Terminated: 2016-11-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148135. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.