Exact FDA event identifier

Event 62538

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

Event summary

Timeline bucket: April 17, 2012
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

4 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 4

High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.

Z-2128-2012

Recall number: Z-2128-2012
Initiated: April 17, 2012
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 4625

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.

Code information

Part Number 423530401 510(k) K052865 Lot#s: 2432974, 2441508, 2448504, 2455568

Distribution pattern

Nationwide distribution

device · product 2 of 4

Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.

Z-2129-2012

Recall number: Z-2129-2012
Initiated: April 17, 2012
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.

Code information

Part Number 460730418 510(k) K052865 Lot number 2444750

Distribution pattern

Nationwide distribution

device · product 3 of 4

94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing

Z-2130-2012

Recall number: Z-2130-2012
Initiated: April 17, 2012
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.

Code information

Part Number B30059 510(k) K964435 Lot number 2418897, 2423996, 2425137, 2430044, 2431861, 2436569, 2443559, 2447238, 2448099, 2452377, 2457453, 2459025, 2464569, 2467687.

Distribution pattern

Nationwide distribution

device · product 4 of 4

Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit

Z-2131-2012

Recall number: Z-2131-2012
Initiated: April 17, 2012
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.

Code information

Part Number AG8137 510(k) K052865 Lot number 2466161

Distribution pattern

Nationwide distribution