Device 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

Z-1795-2020

March 26, 2020

Class II

Product summary

Firm: Becton Dickinson & Company
Event: Event 85380
Status: Terminated
Classification: Class II
Quantity: 900
Official record key: device-enforcement:Z-1795-2020

Official wording

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

Code information: Lot Number: 0001304986

Distribution pattern: Domestic distribution to the following states: Alabama, Colorado, Illinois, Massachusetts, Missouri, Oklahoma, Rhode Island, Virginia, and Wisconsin.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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