Z-2048-2021 Class II Terminated
FDA device recall Z-2048-2021 was initiated by RanD S.r.l. on April 30, 2021 and is designated Class II. Reason for recall: The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile. The recall status is terminated (terminated February 5, 2024). Affected quantity: 72.
Recall Details
- Product Type
- Devices
- Report Date
- July 21, 2021
- Initiation Date
- April 30, 2021
- Termination Date
- February 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72
Product Description
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
Reason for Recall
The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.
Distribution Pattern
The products were distributed to the following US states: FL, IL, TN, WI
Code Information
Lot Numbers: F180266 F180315 F190169