Recall Z-3144-2024— B. Braun Medical, Inc.

Name: FDA recall Z-3144-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-08

Class II · Ongoing

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2024-08-08. It names 3 FDA 510(k) clearances: K111016, K022895, K943770. Product: AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036. Reason: Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-08
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

3 on FDA's record

K111016 — SAFEPORT MANIFOLD (TM) (OR STOPCOCK)Elcam Medical Acal·cleared 2011-06-09
K022895 — ELCAM STOPCOCKS AND MANIFOLDSMedical Device Consultants, Inc.·cleared 2002-10-18
K943770 — LOW VOLUME MULTIPORTB. Braun of America, Inc.·cleared 1995-04-10

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

AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036

Reason for recall

Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.

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