THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Summary
The FDA issued a Class II for THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA by Mallinckrodt Pharmaceuticals Ireland Ltd. Reason: This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage i.
Details
Source
Device Recall
External ID
Z-0567-2022
Action Date
2022-02-16
Status
Ongoing
Category
device
Product Description
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Lot/Code Info: Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341
Quantity Affected: 3
Reason for Recall
This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for customer use.
Distribution
US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-10
Company
Dublin 15, N/A
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 154 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 (Mallinckrodt Pharmaceuticals Ireland Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mallinckrodt Pharmaceuticals Ireland Ltd have FDA actions?
This is the only FDA action we have on record for Mallinckrodt Pharmaceuticals Ireland Ltd in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0567-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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