—#165595

Product

Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K040899, K111386
Affected lot / code info: Barrel Clamp Guide mechanism number: G6000716; Barrel Clamp Guide lot numbers: P0239588, P0321444, and P0462421

Why it was recalled

Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.

Root cause (FDA determination)

Process change control

Action the firm took

Customers were notified of the recall on about 04/13/2018 via URGENT MEDICAL DEVICE RECALL NOTICE letter. Instructions included to evaluate current inventory for affected Barrel Clamp Guide, review and complete the Recall Response Form, return affected Barrel Clamp Guides to Stericycle for destruction, and if the affected Barrel Clamp Guides have already been installed in pumps, continue to use the pumps, but utilize the Syringe Verification Reference Tool provided with the Recall Notice until the pumps are repaired. Customers were also instructed to notify customers if the affected devices were further distributed. Questions regarding the recall can be directed to Stericycle at SmithsMedical5120@stericycle.com.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: US distribution to AL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA. International distribution to Canada and Lebanon.

Timeline

Recall initiated: 2018-04-13
Terminated: 2023-01-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165595. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.