Recall Z-0621-2026— B Braun Medical Inc

Name: FDA recall Z-0621-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-29

Class II · Ongoing

Class II FDA medical device recall by B Braun Medical Inc, initiated 2025-10-29. It names 2 FDA 510(k) clearances: K140311, K781744. Product: Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. BURETTE SET, 4 CARESITE LADS, STPCK 125"; Catalog Number: 490252.. Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion)..

Recalling firm: B Braun Medical Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-10-29
Firm location: Bethlehem, 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
K781744 — IV SET WITH GRADUATED CHAMBERNational Patent Development Corp.·cleared 1978-12-07

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

Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. BURETTE SET, 4 CARESITE LADS, STPCK 125"; Catalog Number: 490252.

Reason for recall

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

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