FDA Medical devices recall ·
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) recall
- Recall number
- Z-1787-2025
- Date
- (initiated April 17, 2025)
- Company / brand
- Cook Incorporated
750 N Daniels Way, Bloomington, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 89 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Why was it recalled?
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
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 00827002089570, Lot Number 16376242
Distribution
Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.
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-1787-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.