Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
Reported: August 26, 2015 Initiated: July 21, 2015 #Z-2362-2015
Product Description
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
Reason for Recall
Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached.
Details
- Recalling Firm
- CareFusion 303, Inc.
- Units Affected
- 68,460 units
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Australia, New Zealand, South Africa, Canada, Middle East, Malaysia, and Taiwan.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.. Recalled by CareFusion 303, Inc.. Units affected: 68,460 units.
Why was this product recalled? ▼
Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 26, 2015. Severity: Critical. Recall number: Z-2362-2015.
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