Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000282, Bard Access S
FDA device recall Z-2019-2009 · posted 2009-09-17 · Terminated
Recall details
- Recalling firm
- C R Bard Inc
- Reason for recall
- Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
- 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.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- KGC
- Quantity affected
- 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.
- Date initiated
- 2009-01-20
- Date posted
- 2009-09-17
- Date terminated
- 2009-12-09
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BUTTON REPLACEMENT GASTROSTOMY DEVICE (K904779) | C.R. Bard, Inc. | 1991-01-18 |