Recall Z-1571-2020
Bard Peripheral Vascular Inc · initiated October 1, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1809600, UDI: (01)00801741027130 ; 2. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture Plugs, REF: 1809601, UDI: (01)00801741027147; 3. PowerPort M.R.I. Implantable Port With Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1859600, UDI: (01)00801741027208 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.
Codes / lots: 1. Lot #s 1809600- RECR1434, RECT0091 2. Lot #s 1809601- RECT0189, 3. Lot #s 1859600- RECR2072, RECS1118
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.
FDA-determined 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
Details
- Recall number
- Z-1571-2020
- Initiated
- October 1, 2019
- Terminated
- February 18, 2022
- Product code
- LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular
- Quantity
- 878 Catheters
- 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.
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1570-2020 Class II | 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1572-2020 Class II | 1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1573-2020 Class II | 1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1574-2020 Class II | 1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2.…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1575-2020 Class II | BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1576-2020 Class II | BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1577-2020 Class II | BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1578-2020 Class II | 1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1579-2020 Class II | PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |