Events

Recall of Device Recall Gemini, Alaris

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardinal Health 303 Inc DBA Alaris Products.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38225
  • Event Risk Class
    Class 2
  • Event Number
    Z-1020-2007
  • Event Initiated Date
    2007-06-18
  • Event Date Posted
    2007-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53191
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    IV Administration Infusion Sets - Product Code FRN
  • Reason
    It has been determined that with low probability, over-infusion may occur as a result of an open safety clamp fitment (a.K.A. flo-stop fitment) on the pumping segment, whether opened intentionally in the course of expected clinical practice, or as a result of inadvertent action. the over-infusion occurrence is dependent on the user not closing the roller clamp first, as required by clinical practi.
  • Action
    The field action will consist of a mailing and will be conducted through consignees (distributors) in the affected countries as well as direct customers for all IV Administration sets intended for use with Gemini Infusion Pumps and Alaris/Medley Pump modules. The customers and distributors will be notified by registered return receipt mail. For direct customers, separate letters will be sent to the Director of Nursing, Director of Materials and Director of Risk Management at each facility. Distributors will be sent multiple copies of the Safety Alert Notification and Tip Sheets; along with a cover letter outlining their responsibilities to complete the Safety Alert plan and notify their customers as requested. The domestic letters (direct customers and distributors) were mailed beginning on June 18, 2007 to all of the affected accounts via US Postal Service Certified Mail.

Device

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
    General Hospital and Personal Use Devices
  • 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
    Cardinal Health 303 Inc DBA Alaris Products

Manufacturer

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