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 |