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U.S. Department of Health and Human Services

Class 2 Device Recall TruGuide Disposable Coaxial Biopsy Needles

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  Class 2 Device Recall TruGuide Disposable Coaxial Biopsy Needles see related information
Date Initiated by Firm February 04, 2016
Create Date October 02, 2018
Recall Status1 Terminated 3 on August 03, 2016
Recall Number Z-1396-2016
Recall Event ID 73249
510(K)Number K936194  
Product Classification Biopsy needle kit - Product Code FCG
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.
Code Information Part Number: C2016B Lot Numbers: REWL0924, REXA1695, REXB1529, REXC1632
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St
Tempe AZ 85281-2438
For Additional Information Contact Raye Seisinger
800-321-4254
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FCG and Original Applicant = BARD GYNECOLOGY AND RADIOLOGY
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