Recall Z-2385-2024— B. Braun Medical, Inc.

Name: FDA recall Z-2385-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-17

Class II · Ongoing

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2024-06-17. It names one FDA 510(k) clearance: K142036. Product: Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363010. Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-06-17
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K142036 — INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETSB.Braun Medical, Inc.·cleared 2014-08-25

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

Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363010

Reason for recall

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

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