Recall Z-0851-2019— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2018-12-21, terminated 2020-04-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571. Reason: The products were manufactured with longer than specified sheaths..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-21
- Terminated
- 2020-04-30
- Firm location
- Bloomington, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.