Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers ar
Summary
The FDA issued a Class II for Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order by Cook Incorporated. Reason: Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the .
Details
Source
Device Recall
External ID
Z-0045-2025
Action Date
2024-10-16
Status
Ongoing
Category
device
Product Description
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
Lot/Code Info: UDI-DI: 00827002272422; Lot Number: 15506769
Quantity Affected: 50 units
Reason for Recall
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
Distribution
International distribution to the country of Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-16
Company
Bloomington, IN
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 123 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 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 (Cook Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cook Incorporated have FDA actions?
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0045-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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