POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
FDA Recall Z-1770-2018 · Posted None
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Recalling FirmBard Peripheral Vascular Inc
Recall StatusCompleted
Product CodeLJT
Date Initiated2018-02-08
Product Quantity1411 units
Reason for Recall
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Firm 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."
Root Cause
Error in labeling
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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