BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
- Company
- Bard Peripheral Vascular Inc
- Recall Initiated
- October 1, 2019
- Terminated
- February 18, 2022
- Recall Number
- Z-1575-2020
- Quantity
- 360 Catheters
- Firm Location
- Tempe, AZ
Reason for Recall
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,VA, VT, WA, WI, WV, WY and countries of Brazil, Canada, EMEA, Korea, Mexico, New Zealand.
Lot / Code Info
Lot # RECR2059
Root Cause
Component change control
Action Taken
On October 1, 2019, Bard sent a "Urgent Medical Device REcall Notification" letter to all customers via FedEx. The recall notification informed customer about the reason for the recall. In addition, to informing customers about the recall, the letter asked that customers take the following actions: 1. Our records show that your facility has purchased product codes affected by this voluntary recall. Do not use or further distribute any affected product. 2. Please check all inventory locations within your 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, 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 your shelves. 4. If you have 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 this recall has been removed from your inventory: 5. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that you intend to return. It is extremely important that we receive this information. 6. Email the completed Recall and Effectiveness Check Form to BDPI.CustomerSupportCenter@bd.com or fax it to BPV at 1-800-994-6772. 7. Once the Recall and Effectiveness Check Form has been completed and emailed to BDPI.CustomerSupportCenter@bd.com or faxed to BPV at 1-800-994-6772 and all information has been verified, the BPV Customer Support Center will issue you a Return Authorization (XC) Number to facilitate the expedient return of the product. BPV will issue a replacement product for your returned product. Please call our BPV Customer Support Center at 1-800-321-4254 Option #5 (M-F 5am to 2pm MST) or email at BDPI.CustomerSupportCenter@bd.com