Device product

VersaSafe Extension Set, Model No. 21000M-007

Z-0435-2014

November 08, 2013

Class II

Product summary

Firm: CareFusion 303, Inc.
Event: Event 66758
Status: Terminated
Classification: Class II
Quantity: 3500 units
Official record key: device-enforcement:Z-0435-2014

Official wording

Reason: CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.

Code information: Lot No. 13066550

Distribution pattern: Nationwide Distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.