—#84196

Product

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.

FDA product code: KGC — Tube, Gastro-Enterostomy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K904779
Affected lot / code info: Lot Numbers: HUSD1611, HUSD1963, HUSD0119, HUSD0120 and HUSD1962.

Why it was recalled

Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

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.

Recalling firm

Firm: C R Bard Inc
Address: 605 N 5600 W, Salt Lake City, Utah 84116-3738

Distribution

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.

Timeline

Recall initiated: 2009-01-20
Posted by FDA: 2009-09-17
Terminated: 2009-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84196. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.