Device product
STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injection and aspiration. The kits are used in the diagnostic section of the radiology department, by medical professionals in a clinical setting.
Z-2162-2019
Product summary
- Event
- Event 83329
- Status
- Terminated
- Classification
- Class II
- Quantity
- 400 each
- Official record key
device-enforcement:Z-2162-2019
Official wording
Reason: Potential for sterile packaging to be compromised
Code information: Lot # 2019020590 Exp : 8/31/2020
Distribution pattern: US Nationwide distribution in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, WI.
Derived failure modes
-
Sterility assurance
sterile packaging to be compromised