Bard Peripheral Vascular Inc Recall 87656
Description: PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: 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.
Bard Peripheral Vascular Inc Recall 87656 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1550-2021 |
| Event ID | 87656 |
| Event Description | PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV. |
| Quantity | 2,194 units |
| Recall Reason | Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. |
| Device Classification | 20210519 |
| Device Code Info | Code: REEU3063, REEV0989, REEV2633, REEX1380, REEZ1991 |
| Center Classification Date | 20210510 |
| Recall Initiation Date | 20210325 |
| Recalling Firm | Bard Peripheral Vascular Inc |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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