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Recall Observatory FDA recall evidence

Device product

98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Z-1595-2015

April 20, 2015

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 71028
Status
Terminated
Classification
Class II
Quantity
50 units
Official record key
device-enforcement:Z-1595-2015

Official wording

Reason: ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

Code information: Lot No. 3019521

Distribution pattern: Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.