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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm November 23, 2005
Date Posted January 18, 2006
Recall Status1 Terminated 3 on February 01, 2006
Recall Number Z-0406-06
Recall Event ID 34145
Product Classification Device, Gas Generating - Product Code KZJ
Product BBL¿ GasPak¿ Pouch System and BBL¿ GasPak¿ CampyPouch¿ System, Catalog numbers 260651 and 260656, packed in boxes of 25
Code Information BBL¿ GasPak¿ Pouch System  Batch Expiration   Date 5214643 08/31/06 5214642 08/31/06 5214640 08/31/06 5194865 08/31/06 5194863 08/31/06 5189360 07/31/06 5189359 07/31/06 5189358 07/31/06 5189357 07/31/05 5189356 07/31/06 5189355 07/31/06 5189353 07/31/06 5182704 07/31/06 5182703 07/31/06 5182702 07/31/06 5182701 07/31/06 5165500 06/30/06 5165499 06/30/06 5165496 06/30/06 5165494 06/30/06 5165491 06/30/06 5158860 06/30/06 5154612 06/30/06 5154610 06/30/06 5152966 06/30/06 5152958 06/30/06 5146724 06/30/06 5126942 05/31/06 5119623 05/31/06 5119622 05/31/06 5119621 05/31/06 5119620 05/31/06 5119619 05/31/06 4345515 12/31/06 5097847 04/30/06 5097845 04/30/06 5097841 04/30/06 5097838 04/30/06 5097837 04/30/06 5074202 03/31/06 5074200 03/31/06 5074198 03/31/06 5069662 03/31/06 5069660 03/31/06 5069659 03/31/06 5061870 03/31/06 5061866 03/31/06 5056474 03/31/06 5056472 03/31/06 5056471 03/31/06 5052074 01/31/06 5052071 01/31/06 5052070 01/31/06 5048914 01/31/06 5040337 01/31/06 5040336 01/31/06 5035915 01/31/06 5035914 01/31/06 5032185 01/31/06 5032184 01/31/06 5031047 01/31/06 5031045 01/31/06 5028254 01/31/06 5021661 01/31/06 5019413 01/31/06 5019411 01/31/06 5013255 01/31/06 5013253 01/31/06 5010278 01/31/06 5010276 01/31/06 5010274 01/31/06 4365412 01/31/06 4355778 12/31/05 4355774 12/31/05 4355771 12/31/05 4352493 12/31/05 4345533 12/31/05 4345531 12/31/05 4345521 12/31/05 4345518 12/31/05 4345515 12/31/05 4343926 12/31/05 4343923 12/31/05 4343922 12/31/05 4341958 11/30/05 4338027 11/30/05 4338025 11/30/05 4338023 11/30/05 4324272 11/30/05 4324271 11/30/05 4324269 11/30/05 4324267 11/30/05 4316041 11/30/05 4316036 11/30/05 4316035 11/30/05 4316033 11/30/05 4316030 11/30/05 4316029 11/30/05 4315197 11/30/05 4315194 11/30/05 4315192 11/30/05 4303939 11/30/05 4303937 11/30/05 4303933 11/30/05 4303932 11/30/05 ********************************************************************************************************* BBL¿ GasPak¿ CampyPouch¿ System  Batch Expiration Date  5164299 8/31/2006 5158868 6/30/2006 5158867 6/30/2006 5158866 6/30/2006 5129239 5/31/2006 5126951 5/31/2006 5126949 5/31/2006 5126947 5/31/2006 5104863 4/30/2006 5104862 4/30/2006 5104859 4/30/2006 5063685 3/31/2006 5063687 3/31/2006 5063684 3/31/2006 5055069 3/31/2006 5048900 2/28/2006 5046481 2/28/2006 5046480 2/28/2006 5042726 2/28/2006 5042721 2/28/2006 5024692 1/31/2006 5024129 1/31/2006 5024120 1/31/2006 5024692 1/31/2006 4335944 12/31/2005 4335943 12/31/2005 4335938 12/31/2005 4335940 12/31/2005 4335932 12/31/2005 4335935 12/31/2005 4303906 11/30/2005 4303857 11/30/2005   
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact Becton Dickinson Technical Services
800-638-8663
Manufacturer Reason
for Recall		 Microbiological based test system may be contaminated with bacteria and cause false clinical test results in patient samples.
FDA Determined
Cause 2		 Other
Action The recalling firm notified distributors by letter on 11/23/05 and advised that identified lots of the devices contain a component contaminated with the bacteria Ralstonia picketti. Distributors were instructed to discontinue distribution and discard. Distributors were requested to provide consignee lists to the recalling firm for direct notification to consignees. Distributors were notified that the recalled products have been discontinued. Customers are asked to discard Liquid Activating Reagent Packets and return the response form enclosed for replacement of the packets or alternatively use existing packets by adding user supplied de-ionized or sterile water into the reagent channel of the pouch.
Quantity in Commerce 61647 boxes of 25/box
Distribution Product was distributed to direct accounts and distributors nationwide and to international affiliated distributors.
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.
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