DT-DL60-1 W/Bifurcated
FDA Recall Z-0073-06 · Posted 2005-10-21
Recalling FirmBecton Dickinson Medical Systems
Recall StatusTerminated
Product CodeKRA
Date Initiated2005-07-01
Date Terminated2011-08-09
Product Quantity620 units
Reason for Recall
Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
Firm Action
Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.
Root Cause
Other
Distribution Pattern
Nationwide, including PR. VA facilities in OH, WA, NV and NY. No military or foreign distribution by US firm..
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.