Epimed International, Inc. Recall 87333
Description: 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
Epimed International, Inc. Recall 87333 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1276-2021 |
Event ID | 87333 |
Event Description | 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 |
Product Type | Devices |
Distribution | US Nationwide distribution |
Quantity | 5835 units |
Recall Reason | Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off |
Device Classification | 20210324 |
Device Code Info | Lot Numbers: 11247915, 11248510, 11248553, 11248938, 11248985, 11249049 |
Center Classification Date | 20210318 |
Recall Initiation Date | 20210201 |
Recalling Firm | Epimed International, Inc. |
Initial Notification | Letter |
Similar To |