FDA Medical Device Recalls (openFDA)
Bard Access Systems: PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico Indicated for patient therapies requiring repeated access to the vascular system for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and blood sample withdrawals.
- Recall number
- Z-1525-2010
- Recalling firm
- Bard Access Systems
- Product
- PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico Indicated for patient therapies requiring repeated access to the vascular system for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and blood sample withdrawals.
- Status
- Terminated
- Initiated
- 2010-03-18
- Posted
- 2010-04-29
- Terminated
- 2010-10-01
- Reason
- 8F PowerPort stems were mixed with 6F PowerPorts and packaged.
- Root cause
- Mixed-up of materials/components
- Action
- The firm, Bard Access Systems, Inc. (BAS) sent a "URGENT: Powerport isp M.R.I with 6F Chronoflex Catheter RECALL" letter dated March 18, 2010, to the customers. The letter describes the product, problem and actions to be taken by customers. The customers were instructed to immediately examine their inventory and quarantine all products subject to this recall and notify any customers they may have distributed the product to; DO NOT USE THIS PRODUCT OR FURTHER DISTRIBUTE ANY OF THE IMPLICATED LOTS; remove and return the affected lots to BAS, and complete and Fax the Reply Form and Inventory Reconciliation Form, if unable to Fax call and report information. Only unused products, in its original packaging, should be returned to BAS. Should you have any questions or require assistance in this matter, please contact BAS Customer Service by calling our toll-free number 1-800-290-1689.
- Quantity
- 200 units total (100 units of each lot, see code information)
- Distribution
- Nationwide distribution: AZ, CA, DC, FL, MA, MD, NC, NE, NV, NY, PA and SC.
- Lot, serial or model codes
- REF#1806061 2 lots: Lot # RETE0854 and RETG1016
- 510(k) numbers
- ["K072549"]
- PMA numbers
- not on file
- Product code
- LJT
- Firm FEI
- 3006260740
- Firm city
- Salt Lake City
- Firm state
- UT
- 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