Z-1772-2018Class II
POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended...
Bard Peripheral Vascular Inc / initiated 2018-02-08 / Completed / root cause: labeling and UDI
Bard Peripheral Vascular Inc began a recall of POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004 on . FDA classified it as Class II and gives the reason as "The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions". As of , the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1772-2018
- Classification
- Class II
- Status
- Completed
- Initiated
- Posted
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
- Product code
- LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
- Reason for recall
- The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- Root cause tag
- labeling and UDI
- FDA root cause
- Error in labeling
- Action
- The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
- Quantity in commerce
- 15 units
- Distribution
- Nationwide
- Product codes and lots
- Lot Number Unique Device Identifier (UDI) REAN0057 (01)00801741110887(17)170628(10)REAN0057 REAN0204 (01)00801741110887(17)170628(10)REAN0204 REAP0770 (01)00801741110887(17)170728(10)REAP0770 REBP0837 (01)00801741110887(17)180131(10)REBP0837
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1760-2018 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1761-2018 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1762-2018 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1763-2018 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1764-2018 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1765-2018 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1766-2018 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1767-2018 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1768-2018 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1769-2018 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1770-2018 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1771-2018 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1772-2018 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-1773-2018 | Class II | Completed | Voluntary: Firm initiated |
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