Device Recall Alaris

General Hospital and Personal Use Devices

2

No

US Nationwide Distribution

Alaris PC unit model 8015, Infusion pump. software version 9.17 || Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.

P/N TC10006587 and 10013801 Lot Numbers 022015502 and 0421151000.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA & WI.

Alaris Medley LVP Frame Membrane. || Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.

P/N 49000204 Lot #'s 031815100, 032415100, 04061545 and 043015215

General Hospital and Personal Use Devices

2

No

Nationwide Distribution in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA & WI.

Alaris Medley LVP Bezel Assembly. || Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution-US (nationwide) and the countries of Australia, New Zealand, South Africa, Canada, Middle East, Malaysia, and Taiwan.

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.

15086733 15086937 15095168 15095332 15095772 15096137 15096516 15086756 15095022 15095212 15095333 15095773 15096183 15096627 15086832 15095045 15095213 15095334 15095842 15096184 15096628 15086833 15095088 15095214 15095347 15095843 15096222 15096629 15086864 15095103 15095254 15095490 15095844 15096291 15096703 15086865 15095128 15095255 15095504 15095936 15096292 15096704 15086910 15095136 15095274 15095505 15096020 15096412 15096722 15086911 15095137 15095275 15095561 15096021 15096413 15096723 15086912 15095166 15095289 15095644 15096050 15096443 15086936 15095167 15095327 15095645 15096125 15096515

General Hospital and Personal Use Devices

2

No

Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, and New Zealand.

Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. || Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.