Recalls / —
—#170557
Product
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
- FDA product code
- DYB — Introducer, Catheter
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- lot 8858425
Why it was recalled
The products were manufactured with longer than specified sheaths.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Urgent Medical Device Recall letters dated 12/21/18 were sent to customers.
Recalling firm
- Firm
- Cook Inc.
- Address
- 750 N Daniels Way, Bloomington, Indiana 47404-9120
Distribution
- Distribution pattern
- The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.
Timeline
- Recall initiated
- 2018-12-21
- Terminated
- 2020-04-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #170557. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.