Z-1041-2019 Class II Terminated
FDA device recall Z-1041-2019 was initiated by COVIDIEN LLC on February 15, 2019 and is designated Class II. Reason for recall: The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution. The recall status is terminated (terminated July 24, 2020). Affected quantity: 25 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- February 15, 2019
- Termination Date
- July 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 units
Product Description
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Reason for Recall
The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
Distribution Pattern
The products were distributed to the following US states: CA, NJ, and WA.
Code Information
Lot Number 83410S09D