Exact FDA event identifier

Event 71028

8 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: April 20, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: ICU Medical, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

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.

Z-1588-2015

Recall number: Z-1588-2015
Initiated: April 20, 2015
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 250 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot No. 2977625 2992751 2995225

Distribution pattern

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

device · product 2 of 8

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.

Z-1589-2015

Recall number: Z-1589-2015
Initiated: April 20, 2015
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 600 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot No. 3002665 3004236 2995225

Distribution pattern

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

device · product 3 of 8

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

Recall number: Z-1590-2015
Initiated: April 20, 2015
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 1,500 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

device · product 4 of 8

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.

Z-1591-2015

Recall number: Z-1591-2015
Initiated: April 20, 2015
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 900 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot No. 2992754 3004256 3007508

Distribution pattern

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

device · product 5 of 8

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

Z-1592-2015

Recall number: Z-1592-2015
Initiated: April 20, 2015
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 13,800 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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

device · product 6 of 8

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.

Z-1593-2015

Recall number: Z-1593-2015
Initiated: April 20, 2015
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 5,100 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot No. 2997914 2997918 2998570 3001230 3001231

Distribution pattern

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

device · product 7 of 8

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.

Z-1594-2015

Recall number: Z-1594-2015
Initiated: April 20, 2015
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 900 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot No. 2997914 2997918 2998570 3001230 3001231

Distribution pattern

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

device · product 8 of 8

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

Recall number: Z-1595-2015
Initiated: April 20, 2015
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 50 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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