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Terminated

BBL GasPak Pouch System and BBL GasPak CampyPouch System, Catalog numbers 260651 and 260656, packed in boxes of 25

FDA Recall Z-0406-06 · Posted 2006-01-18

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeKZJ
Date Initiated2005-11-23
Date Terminated2006-02-01
Product Quantity61647 boxes of 25/box

Reason for Recall

Microbiological based test system may be contaminated with bacteria and cause false clinical test results in patient samples.

Firm 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.

Root Cause

Other

Distribution Pattern

Product was distributed to direct accounts and distributors nationwide and to international affiliated distributors.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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