Device product
CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.
Z-2164-2019
Product summary
- Event
- Event 83329
- Status
- Terminated
- Classification
- Class II
- Quantity
- 168 each
- Official record key
device-enforcement:Z-2164-2019
Official wording
Reason: Potential for sterile packaging to be compromised
Code information: Lot # 2019051390 Exp: 8/31/2021
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