Device product
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices
Z-0865-2016
Product summary
- Firm
- Cook Inc.
- Event
- Event 73163
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25
- Official record key
device-enforcement:Z-0865-2016
Official wording
Reason: Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
Code information: Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Lot: 6166304
Distribution pattern: Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.
Derived failure modes
-
Labeling or packaging
Incorrect packaging