FDA Medical Device Recalls (openFDA)
C R Bard Inc: Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 2.4cm, NON STERILE, REF 000283, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.
- Recall number
- Z-2020-2009
- Recalling firm
- C R Bard Inc
- Product
- Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 2.4cm, NON STERILE, REF 000283, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.
- Status
- Terminated
- Initiated
- 2009-01-20
- Posted
- 2009-09-17
- Terminated
- 2009-12-09
- Reason
- Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
- Root cause
- Equipment maintenance
- Action
- Customers were notified by letter and instructed to not use or further distribute any of the affected lot numbers. Customers were further instructed to return the recalled products to Bard Access Systems (BAS) through a return goods authorization number. Questions and requests for assistance should be directed to BAS Customer Service at 800-290-1689.
- Quantity
- 13, 337 total of all products
- Distribution
- Worldwide Distribution -- US, Canada, Austria, Australia, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, Sweden and Switzerland, Japan, and Latin America.
- Lot, serial or model codes
- Lot numbers: HUSD0118, HUSD1610 and HUSD0116.
- 510(k) numbers
- ["K904779"]
- PMA numbers
- not on file
- Product code
- KGC
- 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