FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media.
- Recall number
- Z-1964-2020
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media.
- Status
- Open, Classified
- Initiated
- 2020-01-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
- Root cause
- Employee error
- Action
- The recalling firm issued letters dated 1/15/2020 via FedEx with proof of delivery notification. The devices were to be returned.
- Quantity
- 200 units
- Distribution
- US Nationwide distribution including in the states of AZ, CA, MA, MD, NJ, NY, and TX. There was no foreign/government/military distribution.
- Lot, serial or model codes
- Lot #RECX3530, Exp. date 4/30/2020, UDI (01)00801741110771(17)200430(10)RECX3530.
- 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