Z-0490-2019 Class II Terminated
FDA device recall Z-0490-2019 was initiated by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company on September 5, 2017 and is designated Class II. Reason for recall: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. The recall status is terminated (terminated September 23, 2024). Affected quantity: 10,440.
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2018
- Initiation Date
- September 5, 2017
- Termination Date
- September 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,440
Product Description
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Reason for Recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Distribution Pattern
AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, and WI
Code Information
Model # FB-A-400-107 Lot Number: 4J006