FDA Medical Device Recalls (openFDA)
C.R. Bard Access Systems, Inc: Bard Access Systems, Inc., FASTRAC "Pull" Gastric Access Port Kit, REF 005729, 20F, Sterile.
- Recall number
- Z-2184-2009
- Recalling firm
- C.R. Bard Access Systems, Inc
- Product
- Bard Access Systems, Inc., FASTRAC "Pull" Gastric Access Port Kit, REF 005729, 20F, Sterile.
- Status
- Terminated
- Initiated
- 2008-12-04
- Posted
- 2009-09-15
- Terminated
- 2011-11-09
- Reason
- Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.
- Root cause
- Nonconforming Material/Component
- Action
- Bard contacted all 1,883 worldwide customers who received the distributed suspect 467 product code lots, comprising 177, 614 units that were either not expired or were still available in the field. These will be returned by the customer to Bard Access Systems. 1-800-290-1689.
- Quantity
- 177,614 units
- Distribution
- Worldwide, including USA, Belgium, Canada, Australia, and Japan.
- Lot, serial or model codes
- Lots: 43ARA101, 43FQA079, 43IQA080, 43JQA077, 43KPA083, 43KPA084, 43KPA085, 43KQA101, 43LQA101, HURC9281, HURC9529, HURD0640,HURD1797, HURE3297, HURE3298, HURF0403, HURJ0538, HURJ1432, HURK1454, HUSA0272, HUSA0273, HUSC0638, HUSD1932, HUSE1504, HUSF1736, HUSG0963, HUSG0964, HUSH1585, HUSH1586.
- 510(k) numbers
- ["K033562","K061021","K915841","K972025","K972101"]
- PMA numbers
- not on file
- Product code
- KNT
- 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