Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Summary
The FDA issued a Class II for Infusomat Space Volumetric Pump Administration Set, Product Code 490100 by B. Braun Medical, Inc.. Reason: There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to fo.
Details
Source
Device Recall
External ID
Z-2137-2021
Action Date
2021-08-04
Status
Terminated
Category
device
Product Description
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Lot/Code Info: Lot Number: 0061761278
Quantity Affected: 36,144 units
Reason for Recall
There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.
Distribution
Affected products were distributed to the following US states: CA, MI, OR, and UT.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-25
Company
Allentown, 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 173 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-2137-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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