Device product
Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less
Z-1276-2021
Product summary
- Event
- Event 87333
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5835 units
- Official record key
device-enforcement:Z-1276-2021
Official wording
Reason: Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Code information: Lot Numbers: 11247915, 11248510, 11248553, 11248938, 11248985, 11249049
Distribution pattern: US Nationwide distribution
Derived failure modes
-
Unknown
Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off