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Recall Observatory FDA recall evidence

Device product

Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007

Z-1179-2016

February 15, 2016

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 73238
Status
Terminated
Classification
Class II
Quantity
5,760 units
Official record key
device-enforcement:Z-1179-2016

Official wording

Reason: CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.

Code information: Lot No. 13085603

Distribution pattern: Michigan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.