Z-0851-2019 Class II Terminated
FDA device recall Z-0851-2019 was initiated by Cook Inc. on Dec 21, 2018 and is designated Class II. Reason for recall: The products were manufactured with longer than specified sheaths. The recall status is terminated (terminated Apr 30, 2020). Affected quantity: 24.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 27, 2019
- Initiation Date
- Dec 21, 2018
- Termination Date
- Apr 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
Reason for Recall
The products were manufactured with longer than specified sheaths.
Distribution Pattern
The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.
Code Information
lot 8858425
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0851-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026