Z-0783-2021 Class II Terminated
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
- 360
Product Description
Cardiac Pack - LF, Model DYNJ31903I - 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 20GBG768 (Expiration: 11/30/2021); 20HBO067 (Expiration: 02/28/2022); Lot 20IBC642 (Expiration 03/31/2022)