MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe
FDA device recall Z-2121-2010 · posted 2010-08-02 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Smiths Medical is conducting a correction of Medfusion Syringe Infusion Pumps, Models 3010 and 3010a, with obsolete software versions 2.0.2, 2.0.3, and 2.0.4. Smiths Medical has found that pumps with obsolete software may continue to run past the set volume limit. This can result in an over-delivery if the syringe is over-filled. Smiths Medical has received no reports of serious patient in
- Action taken
- Consignees were sent on 6/22/10 a Smith Medical "Urgent Medical Device Correction Notice', dated June 11, 2010. The letter was addressed to Dear Risk/ Safety Managers, Distributors, Clinical/ Biomedical Engineering, Clinicians, Critical Care Physicians, Pediatricians, Pediatric Intensivists, Neonatologists; and Nursing, Pharmacy,and Anesthesia Professionals. The letter described the problem and product involved. It provided Advise on Action to be Taken by the User which included to 1) Determine the software version of their Medfusion pump 2. Complete and return the Confirmation Form 3. Return the completed Software Update Test Form 4. If unable or unwilling to perform the software upgrade they provided information for returning the pumps to Smiths Medical for the upgrade. For further information please contact Smiths Medical at 651-628-7280.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 4816
- Distribution
- Worldwide Distribution: AL, AK, AZ, AR, CA,CO, CT, DC, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV,NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV,
- Date initiated
- 2010-06-22
- Date posted
- 2010-08-02
- Date terminated
- 2012-04-17
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP (K040899) | Medex, Inc. | 2004-04-30 |