Class 2 Device Recall Bard Access Systems PowerPort isp M.R.I. Implantable Port

• Date Initiated by Firm: February 14, 2019
• Create Date: November 27, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0582-2020
• Recall Event ID: 84169
• 510(K)Number: K063377
• Product Classification: Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
• Product: PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
• Code Information: Product Code: 1808060 Device Listing Number: D004935 UDI: (01)00801741027031(17)191130(10)RECS2407 Lot Number: RECS2407
• Recalling Firm/ Manufacturer: Bard Peripheral Vascular Inc; 1625 W 3rd St Bldg 1; Tempe AZ 85281-2438
• For Additional Information Contact: Garth Conrad; 480-303-2602
• Manufacturer Reason for Recall: Complaints received that products packaged with the incorrect introducer sheath size.
• FDA Determined Cause: Process control
• Action: On 2/14/2019, the firm sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" via FedEx informing them the firm has identified one product code/lot number (RECS2407) may be at risk of incorrectly containing a 6.5Fr introducer sheath instead of an 8Fr introducer sheath. Customer are instructed to: 1. Do not use or further distribute any affected product. 2. Check all inventory locations within their institution for affected product code / lot number combinations listed in the recall notice. If you have further distributed any of the product code / lot numbers, and to immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to the Recalling Firm. 3. Remove any identified product from their shelves. 4. If the customers have used the affected product, to complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by this recall has been removed from customer inventory: 5. Fill out the Recall and Effectiveness Check Form and to be sure to state the quantities and lot numbers of each recalled product that is intended to be returned. It is extremely important that the Recalling Firm receive this information. 6. Please call Customer Support Center at 1-800-321-4254 Option #5 (M-F 6am to 3pm MST) or email at BPV.CustomerSupportCenter@crbard.com. Once all information has been verified, Customer Support Center will issue you a Return Authorization (XC) Number to facilitate the expedient return of the product. The Recalling Firm will issue a replacement product for its customer's returned product. 7. Email the completed Recall and Effectiveness Check Form to BPV.CustomerSupportCenter@crbard.com or fax it to BPV at 1-800-994-6772. If you cannot email or FAX the form, please call Customer Support Center at 1-800-321-4254 Option #5 and report the required information verbally. 8. A mailing label will be enclosed for the custo
• Quantity in Commerce: 900 units
• Distribution: US - Nationwide OUS - None
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LJT