Z-0702-2019 Class II Terminated
FDA device recall Z-0702-2019 was initiated by Cardinal Health Inc. on Nov 16, 2018 and is designated Class II. Reason for recall: The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation. The recall status is terminated (terminated Nov 4, 2019). Affected quantity: 182 packs.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 16, 2019
- Initiation Date
- Nov 16, 2018
- Termination Date
- Nov 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 182 packs
Product Description
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
Reason for Recall
The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
Distribution Pattern
US state of Florida
Code Information
Product code: SOP22TJCLK Lot numbers # 104405, 122793, and 987948
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0702-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026