FDA Medical devices recall ·
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J… recall
- Recall number
- Z-0045-2025
- Date
- (initiated September 16, 2024)
- Company / brand
- Cook Incorporated
750 N Daniels Way, Bloomington, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 50 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00827002272422; Lot Number: 15506769
Distribution
International distribution to the country of Australia.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0045-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.