FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
- Recall number
- Z-1768-2018
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
- Status
- Completed
- Initiated
- 2018-02-08
- Posted
- not on file
- Terminated
- not on file
- Reason
- The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 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
- 3196 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Number Unique Device Identifier (UDI) REAN0055 (01)00801741110771(17)170628(10)REAN0055 REAN0202 (01)00801741110771(17)170528(10)REAN0202 REAP0771 (01)00801741110771(17)170828(10)REAP0771 REAS1708 (01)00801741110771(17)171028(10)REAS1708 REAT0147 (01)00801741110771(17)171128(10)REAT0147 REAT1852 (01)00801741110771(17)171228(10)REAT1852 REAU1811 (01)00801741110771(17)171228(10)REAU1811 REAU2420 (01)00801741110771(17)171228(10)REAU2420 REAV2465 (01)00801741110771(17)180228(10)REAV2465 REAW1422 (01)00801741110771(17)180331(10)REAW1422 REAW1831 (01)00801741110771(17)180331(10)REAW1831 REAX1132 (01)00801741110771(17)180331(10)REAX1132 REAY1623 (01)00801741110771(17)180331(10)REAY1623 REAY2597 (01)00801741110771(17)180331(10)REAY2597 REBP0090 (01)00801741110771(17)180331(10)REBP0090 REBS1269 (01)00801741110771(17)181031(10)REBS1269 REBR1002 (01)00801741110771(17)181031(10)REBR1002 REBS1439 (01)00801741110771(17)181031(10)REBS1439 REBT1052 (01)00801741110771(17)181231(10)REBT1052 REBT2348 (01)00801741110771(17)181231(10)REBT2348 REBV0714 (01)00801741110771(17)190131(10)REBV0714 REBV1758 (01)00801741110771(17)190131(10)REBV1758 REBW1288 (01)00801741110771(17)190331(10)REBW1288 REBX1628 (01)00801741110771(17)190331(10)REBX1628 REBX2052 (01)00801741110771(17)190430(10)REBX2052
- 510(k) numbers
- ["K122899"]
- PMA numbers
- not on file
- Product code
- LJT
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28