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U.S. Department of Health and Human Services

Class 2 Device Recall Gemini, Alaris

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  Class 2 Device Recall Gemini, Alaris see related information
Date Initiated by Firm June 18, 2007
Date Posted August 02, 2007
Recall Status1 Terminated 3 on March 28, 2012
Recall Number Z-1020-2007
Recall Event ID 38225
510(K)Number K862295  
Product Classification IV Administration Infusion Sets - Product Code FRN
Product 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
Code Information 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
Recalling Firm/
Manufacturer		 Cardinal Health 303 Inc DBA Alaris Products
10221 Wateridge Cir
San Diego CA 92121-2733
For Additional Information Contact Stacy L. Lewis
858-458-7563
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce >2,000,000 units produced annually
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = IMED CORP.
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