FDA Medical Device Recalls (openFDA)
Cardinal Health 303 Inc DBA Alaris Products: 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
- Recall number
- Z-1020-2007
- Recalling firm
- Cardinal Health 303 Inc DBA Alaris Products
- 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
- Status
- Terminated
- Initiated
- 2007-06-18
- Posted
- 2007-08-02
- Terminated
- 2012-03-28
- 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
- Root cause
- 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
- >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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K862295"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3003879246
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28