Recall Z-2021-2009 ยท KGC Tube, Gastro-Enterostomy
C R Bard Inc
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.
| Date | Sep 17, 2009 (initiated Jan 20, 2009) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904779 | BUTTON REPLACEMENT GASTROSTOMY DEVICE C.R. Bard, Inc., Jan 18, 1991 |