Z-2021-2009

Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000284...

Name: Z-2021-2009 Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000284...
Creator: C R Bard Inc
Published: 2009-01-20
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2009-01-20 / Terminated / root cause: manufacturing process

FDA source

C R Bard Inc began a recall of Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000284, Bard Access Systems, Inc., Salt Lake City, UT 84116... on 2009-01-20. The reason FDA records is "Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2021-2009
Status: Terminated
Initiated: 2009-01-20
Posted: 2009-09-17
Terminated: 2009-12-09
Recalling firm: Bard Access Systems, Inc.
Product: Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000284, 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.
Product code: KGC Tube, Gastro-Enterostomy
Reason for recall: Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers: HUSD1611, HUSD1963, HUSD0119, HUSD0120 and HUSD1962.

Product code KGC

K904779Class IIButton Replacement Gastrostomy DeviceC.R. Bard, Inc. / cleared 1991-01-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)