Device product
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
Z-0851-2019
Product summary
- Firm
- Cook Inc.
- Event
- Event 82007
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24
- Official record key
device-enforcement:Z-0851-2019
Official wording
Reason: The products were manufactured with longer than specified sheaths.
Code information: lot 8858425
Distribution pattern: The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.
Derived failure modes
-
Unknown
The products were manufactured with longer than specified sheaths.