Recall Z-1795-2020— Becton Dickinson & Company

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2020-03-26, terminated 2020-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986. Reason: The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle..

Recalling firm
Becton Dickinson & Company
Classification
Class II
Status
Terminated
Initiated
2020-03-26
Terminated
2020-08-21
Firm location
Franklin Lakes, NJ, United States

Product description

CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986

Reason for recall

The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.

Data sourced from openFDA. This site is unofficial and independent of the FDA.