Summary
The FDA issued a Class II for Perifix¿ / Epidural anesthesia kit (10 count carton) by B. Braun Medical, Inc.. Reason: Kits were assembled with the incorrect Filter Straw..
Details
Source
Device Recall
External ID
Z-2002-2023
Action Date
2023-07-05
Status
Ongoing
Category
device
Product Description
Perifix¿ / Epidural anesthesia kit (10 count carton)
Lot/Code Info: Model No. 332217, 332097, 332220, 332078; GTIN: 04046964178283, 04046964177361, 04046964177361, 04046964178320, 04046964177200; Lot No. 0061850767, 0061855339, 00618553400061858554, 0061837264.
Quantity Affected: 16,070 units
Reason for Recall
Kits were assembled with the incorrect Filter Straw.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-05
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 367 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-2002-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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