Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE, REF 000256, 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.
FDA Recall Z-2017-2009 · Posted 2009-09-17
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Recalling FirmC R Bard Inc
Recall StatusTerminated
Product CodeKGC
Date Initiated2009-01-20
Date Terminated2009-12-09
Product Quantity13, 337 total of all products
Reason for Recall
Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
Firm 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.
Root Cause
Equipment maintenance
Distribution Pattern
Worldwide Distribution -- US, Canada, Austria, Australia, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, Sweden and Switzerland, Japan, and Latin America.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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