Recall Z-0935-2020— B. Braun Medical, Inc.

Name: FDA recall Z-0935-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-20

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2019-11-20, terminated 2020-10-16. It names 2 FDA 510(k) clearances: K140311, K922637. Product: Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005. Reason: Potential for leakage at the joint between the blood filters and tubing.

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-11-20
Terminated: 2020-10-16
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K140311 — CARESITE LUER ACCESS DEVICEB.Braun Medical, Inc.·cleared 2014-05-07
K922637 — HORIZON PUMP Y-TYPE BLOOD SETMcgaw, Inc.·cleared 1993-06-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.