Recall Z-0406-06 ยท KZJ Device, Gas Generating
Becton Dickinson & Co.
BBL GasPak Pouch System and BBL GasPak CampyPouch System, Catalog numbers 260651 and 260656, packed in boxes of 25
| Date | Jan 18, 2006 (initiated Nov 23, 2005) |
| Status | Terminated |
| Reason | Microbiological based test system may be contaminated with bacteria and cause false clinical test results in patient samples. |
| Root cause | 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 |
| Quantity | 61647 boxes of 25/box |
| Distribution | Product was distributed to direct accounts and distributors nationwide and to international affiliated distributors. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.