Device Recall Gemini, Alaris

  • Model / Serial
    The 173 models of the dedicated administration sets for use with Gemini Infusion Pumps and Alaris Pump module (a.k.a. Medley Pump module) affected by this issue are: 10010453, 10010454, 10010483, 10010541, 10010547, 10010761, 10010871, 10010916, 10011221, 10011301, 10011462, 10011652, 10012144, 10012182, 10012283, 10012293, 10012645, 10012802, 10013034, 10013037, 10013072, 10013186, 10013361, 10013373, 10013373, 10013374, 10013854, 10013889, 10013890, 10013923, 10014035, 10014855, 10015012, 10015048, 10015294, 10015312, 10015362, 10015364, 10015366, 10015366, 10015368, 10015370, 10015414, 10015489, 10015514, 10015645, 10015649, 10015861, 10015862, 10015896, 10031773, 10061661, 10062818, 10074281, 10108961, 10137405, 10142568, 10178573, 2110-0500, 2111-0500, 2120-0500, 2125-0500, 2126-0500, 2130-0500, 2131-0500, 2140-0600, 2141-0600, 2147-0600, 2177-0000, 2200-0006, 2200-0500, 2202-0500, 2203-0006, 2205-0000, 2210-0006, 2210-0500, 2211-0500, 2214-0001, 2214-0006, 2220-0006, 2220-0500, 2225-0500, 2226-0500, 2230-0500, 2231-0006, 2231-0500, 2240-0008, 2240-0600, 2241-0001, 2241-0006, 2241-0008, 2241-0600, 2247-0600, 2248-0600, 2255-0001, 2255-0500, 2260-0001,2260-0006, 2260-0008, 2260-0500, 2264-0006, 2264-0008, 2264-0500, 2277-0000, 2277-0006, 2277-0008, 2279-0006, 2280-0000, 2301-0500, 2377-0000, 2401-0006, 2401-0500, 2403-0000, 2403-0007, 2406-0500, 2410-0500, 2411-0500, 2412-0500, 2414-0006, 2420-0006, 2420-0007, 2420-0500, 2421-0500, 2425-0500, 2426-0500, 2430-0500, 2431-0500, 2440-0600, 2441-0007, 2441-0600, 2443-0600, 2447-0600, 2448-0600, 2449-0600, 2455-0500, 2464-0500, 2477-0000, 2477-0007, 2478-0000, 2904-0600, 2906-0000, 2906-0001, 2907-0000, 2907-0006, 2920-0000, 2929-0500, 2941-0500, 2942-0500, 2946-0600, 9943-0000, 9943-0001, 9943-0008, 9943T, 9943T-0008, 9950-0500, 9952-0500, 9953-0500, 9966-0006, 9971-0600, 9974-0600, C24101E, C24102M, C24103E, C24104E, C24105E, C24106E, C24107E, C24109E, C24111E, C24112, C24114E, C24116E, C24117, C24119E, C24120E
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including USA, Argentina, Australia, Bahrain, Belgium, Canada, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malta, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Qatar, Saudi Arabia, Serbia/Montenegro, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad &Tobago;, United Kingdom, United Arab Emirates, Uruguay & Venezuela.
  • Product Description
    All IV Administration Infusion Sets intended for use with the Gemini Infusion Pump and Alaris Pump module (a.k.a. Medley Pump module) including: Alaris SmartSite Low Sorbing Set, Alaris Vented Syringe Adapter Set, Alaris Burette Set, Cardinal Health SmartSite Infusion Set, Alaris Infusion Set, Alaris SmartSite Burette Set, Cardinal Health SmartSite Burette Set, Alaris SmartSite Administration Set, Alaris Infusion Burette Set, Alaris SmartSite Blood Set, Cardinal Health SmartSite Combination Infusion Set, Cardinal Health Blood Set, Alaris Medley/Gemini Infusion Set, Alaris Medley/Gemini Blood Set, Alaris Latex-Free Infusion Set, Alaris Light Sensitive Solution Set, Alaris Medley/Gemini Enteral Set, Imed Gemini 20 Vented/Nonvented Primary Administration Set, Imed Vented/Nonvented Gemini Prime-Saver Set, Imed Vented/Nonvented Gemini Short Set, Alaris Half Set, Cardinal Health Half Set, Alaris Latex-Free Burette Set, Alaris Opaque Set, Alaris Medley/Gemini Combination Infusion Set
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Cardinal Health 303 Inc DBA Alaris Products, 10221 Wateridge Cir, San Diego CA 92121-2733
  • Source
    USFDA