Z-0937-2020 Class II Terminated
FDA device recall Z-0937-2020 was initiated by B. Braun Medical, Inc. on November 20, 2019 and is designated Class II. Reason for recall: Potential for leakage at the joint between the blood filters and tubing The recall status is terminated (terminated October 16, 2020). Affected quantity: 5,616 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- November 20, 2019
- Termination Date
- October 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,616 units
Product Description
Y-Type Blood Set, Catalog Number 490314
Reason for Recall
Potential for leakage at the joint between the blood filters and tubing
Distribution Pattern
US Nationwide
Code Information
GUIDID: 04046964527180 Lot Numbers: 61674868 - Expiration Date April 30, 2022, 61677175 - Expiration Date April 30, 2022, 61678259 - Expiration Date May 31, 2022, 61685087 - Expiration Date June 30, 2022