Summary
The FDA issued a Class II for THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA by Therakos, Inc.. Reason: Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury..
Details
Source
Device Recall
External ID
Z-0212-2022
Action Date
2021-11-17
Status
Ongoing
Category
device
Product Description
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Lot/Code Info: LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201
Quantity Affected: Five (5) Cases -3 Kits/Case= 15 Kits
Reason for Recall
Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
Distribution
IL
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-04
Company
West Chester, 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 102 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Therakos, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Therakos, Inc. have FDA actions?
This is the only FDA action we have on record for Therakos, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0212-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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