QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36 The Transp...

FDA Device Recall #Z-0523-2017 — Class II — September 27, 2016

Recall Summary

Recall Number Z-0523-2017
Classification Class II — Moderate risk
Date Initiated September 27, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ICU Medical, Inc.
Location San Clemente, CA
Product Type Devices
Quantity 70 units

Product Description

QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

Reason for Recall

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Distribution Pattern

Nationwide Distribution

Lot / Code Information

3226751

Other Recalls from ICU Medical, Inc.

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Z-1111-2026 Class II Tego Connector: REF: 011-D1000, 01C-D1000, 055-... Dec 19, 2025
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Z-1119-2026 Class II ICU Medical Plum Duo Precision IV Pump, List Nu... Dec 15, 2025
Z-1120-2026 Class II ICU Medical Plum Solo Precision IV Pump, List N... Dec 15, 2025
Z-1118-2026 Class II ICU Medical Plum Duo Infusion Pump, List Number... Dec 15, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.