Z-0781-2021 Class II Terminated
FDA device recall Z-0781-2021 was initiated by Medline Industries Inc on November 13, 2020 and is designated Class II. Reason for recall: The cylindrical sponge component is not x-ray detectable. The recall status is terminated (terminated October 26, 2021). Affected quantity: 40.
Recall Details
- Product Type
- Devices
- Report Date
- January 13, 2021
- Initiation Date
- November 13, 2020
- Termination Date
- October 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40
Product Description
Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Reason for Recall
The cylindrical sponge component is not x-ray detectable.
Distribution Pattern
Foreign distribution only - Canada.
Code Information
Lot 20HBM370 (Expiration 02/28/2025); 20IBB678 (Expiration 03/31/2025); 20KBP338 (Expiration Date: 05/31/2025 never distributed)