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Recall Observatory FDA recall evidence

Device product

104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubing, Item No. B33065 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Z-1590-2015

April 20, 2015

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 71028
Status
Terminated
Classification
Class II
Quantity
1,500 units
Official record key
device-enforcement:Z-1590-2015

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. 2992752 2997916 3004237 3019517 3026353

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.