Summary
The FDA issued a Class II for Perifix¿ / Epidural anesthesia set, medicated by B. Braun Medical, Inc.. Reason: Product may be mislabeled with an incorrect lid stock label..
Details
Source
Device Recall
External ID
Z-2627-2023
Action Date
2023-09-27
Status
Ongoing
Category
device
Product Description
Perifix¿ / Epidural anesthesia set, medicated
Lot/Code Info: UDI-DI: 04046964178726 Product Code: 332250; Lot Number 0061863524, expiration date 30.APR.2025
Quantity Affected: 3440 units
Reason for Recall
Product may be mislabeled with an incorrect lid stock label.
Distribution
US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA, TX, WA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-31
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 195 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-2627-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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