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U.S. Department of Health and Human Services

Class 2 Device Recall BUTTON REPLACEMENT GASTROSTOMY DEVICE

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  Class 2 Device Recall BUTTON REPLACEMENT GASTROSTOMY DEVICE see related information
Date Initiated by Firm January 20, 2009
Date Posted September 17, 2009
Recall Status1 Terminated 3 on December 09, 2009
Recall Number Z-2019-2009
Recall Event ID 52862
510(K)Number K904779  
Product Classification Tube, gastro-enterostomy - Product Code KGC
Product Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000282, 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.
Code Information Lot Numbers: HUSD1960 and HUSD1959. 
Recalling Firm/
Manufacturer		 C R Bard Inc
605 N 5600 W
Salt Lake City UT 84116-3738
For Additional Information Contact
908-227-8481
Manufacturer Reason
for Recall		 Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KGC and Original Applicant = C.R. BARD, INC.
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