Z-2162-2019 Class II Terminated
FDA device recall Z-2162-2019 was initiated by Centurion Medical Products Corporation on July 1, 2019 and is designated Class II. Reason for recall: Potential for sterile packaging to be compromised The recall status is terminated (terminated June 26, 2020). Affected quantity: 400 each.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- July 1, 2019
- Termination Date
- June 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400 each
Product Description
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.
Reason for Recall
Potential for sterile packaging to be compromised
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.
Code Information
Lot # 2019020590 Exp : 8/31/2020