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

Agency Publication Date: May 7, 2015

Affected Products

Product: 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Lot No. 2977625 2992751 2995225

Product: 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Lot No. 3002665 3004236 2995225

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.

Lot No. 2992752 2997916 3004237 3019517 3026353

Product: 113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP Tubing, Item No. B33303 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Lot No. 2992754 3004256 3007508

Product: 108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326

Lot No. 2997915 2997919 2997920 2998568 2998569 3001232 3001233 3001234 3004257 3015880 3015881 3019519 3020159

Product: 127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Lot No. 2997914 2997918 2998570 3001230 3001231

Product: 98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Lot No. 2997914 2997918 2998570 3001230 3001231

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.

Lot No. 3019521

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71028

Status: Resolved

Manufacturer: ICU Medical, Inc.

Manufactured In: United States

Units Affected: 8 products (250 units; 600 units; 1,500 units; 900 units; 13,800 units; 5,100 units; 900 units; 50 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Lot No. 2977625 2992751 2995225

Lot No. 3002665 3004236 2995225

Lot No. 2992752 2997916 3004237 3019517 3026353

Lot No. 2992754 3004256 3007508

Product: 108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326

Lot No. 2997915 2997919 2997920 2998568 2998569 3001232 3001233 3001234 3004257 3015880 3015881 3019519 3020159

Lot No. 2997914 2997918 2998570 3001230 3001231

Lot No. 3019521