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.
This recall has been terminated (originally issued September 17, 2009).
- Company
- C R Bard Inc
- Recall Initiated
- January 20, 2009
- Posted
- September 17, 2009
- Terminated
- December 9, 2009
- Recall Number
- Z-2020-2009
- Quantity
- 13, 337 total of all products
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
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 / Code Info
Lot numbers: HUSD0118, HUSD1610 and HUSD0116.
Root Cause
Equipment maintenance
Action Taken
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.