Recall Z-1509-2021— B. Braun Medical, Inc.

Name: FDA recall Z-1509-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-15

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2021-03-15, terminated 2022-06-07. It names 2 FDA 510(k) clearances: K153293, K942988. Product: Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.. Reason: BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-03-15
Terminated: 2022-06-07
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K153293 — Extension SetB.Braun Medical, Inc.·cleared 2016-04-06
K942988 — FILTERED EXTENSION SETSB. Braun of America, Inc.·cleared 1995-07-14

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

Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.

Reason for recall

BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.

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