IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus
Summary
The FDA issued a Class II for IV Administration Set utilized in gravity IV administration sets and pump admini by B Braun Medical Inc. Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion)..
Details
Source
Device Recall
External ID
Z-0687-2026
Action Date
2025-12-03
Status
Ongoing
Category
device
Product Description
IV Administration 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. IV ADMIN SET W/CARESITE EXT SET; Catalog Number: 490407.
Lot/Code Info: 1. Catalog Number: 490407; Primary UDI-DI: 04046964773242; Unit of Dose UDI-DI: 04046964773235; Expiration Date: Earliest Exp of Comp or 36mths.
Quantity Affected: 10,896 units
Reason for Recall
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Distribution
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-29
Company
Bethlehem, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 403 device-related FDA actions this month.
B Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B Braun Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B Braun Medical Inc have FDA actions?
B Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0687-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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