Z-0939-2020 Class II Terminated

Recalled by B. Braun Medical, Inc. — Allentown, PA

FDA device recall Z-0939-2020 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: 9,000 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
9,000 units

Product Description

Y-Type Blood Set, Catalog Number 490530

Reason for Recall

Potential for leakage at the joint between the blood filters and tubing

Distribution Pattern

US Nationwide

Code Information

GUIDID: 04046955203321 Lot Numbers: 61674878 - Expiration Date: April 30, 2022, 61677192 - Expiration Date: April 30, 2022, 61678186 - Expiration Date: April 30, 2022, 61681736 - Expiration Date: May 31, 2022, 61685105 - Expiration Date: June 30, 2022