FDA Medical Device Recalls (openFDA)
Bard Access Systems, Inc: Groshong NXT ClearVue 4 Fr. Single-Lumen PICC, Bard Access Systems, Inc.
- Recall number
- Z-0542-06
- Recalling firm
- Bard Access Systems, Inc
- Product
- Groshong NXT ClearVue 4 Fr. Single-Lumen PICC, Bard Access Systems, Inc.
- Status
- Terminated
- Initiated
- 2005-12-20
- Posted
- 2006-03-16
- Terminated
- 2009-08-11
- Reason
- Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.
- Root cause
- Other
- Action
- Consignees were notified by letter on 12/20/2005.
- Quantity
- 450
- Distribution
- Nationwide, including VA facilities in CA, FL and IL. No foreign or military distribution.
- Lot, serial or model codes
- Product Code 7617408, Lot #REPI0738
- 510(k) numbers
- ["K023374","K034020"]
- PMA numbers
- not on file
- Product code
- LJS
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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