Z-2662-2018 Class II Terminated
FDA device recall Z-2662-2018 was initiated by Smiths Medical ASD Inc. on Apr 13, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jan 30, 2023). Affected quantity: 276 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 15, 2018
- Initiation Date
- Apr 13, 2018
- Termination Date
- Jan 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 276 units
Product Description
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Reason for Recall
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.
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.
Code Information
Barrel Clamp Guide mechanism number: G6000716; Barrel Clamp Guide lot numbers: P0239588, P0321444, and P0462421
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2662-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026