Recall Z-2020-2009
C R Bard Inc · initiated January 20, 2009
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.
Codes / lots: Lot numbers: HUSD0118, HUSD1610 and HUSD0116.
Reason for recall
Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
FDA-determined 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.
Details
- Recall number
- Z-2020-2009
- Initiated
- January 20, 2009
- Posted by FDA
- September 17, 2009
- Terminated
- December 9, 2009
- Product code
- KGC – Tube, Gastro-Enterostomy
- 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.
- Recalling firm
- C R Bard Inc, Salt Lake City, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2017-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | 01/20/2009Terminated |
| Z-2018-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.2cm, NON…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | 01/20/2009Terminated |
| Z-2019-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | 01/20/2009Terminated |
| Z-2021-2009 | Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON…Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine… | 01/20/2009Terminated |