FDA Device recall Z-2012-2018
TheraCath(R) Epidural Catheter
- FDA Device
- Class II
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class II recall of TheraCath(R) Epidural Catheter by Arrow International, citing product sterility may be compromised due to unsealed packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2012-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-11 |
| Published | 2018-06-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | US |
Product
TheraCath(R) Epidural Catheter; Product Code: EC-05000
Reason
Product sterility may be compromised due to unsealed packaging.
Identifiers
| code_info | Lot Numbers: 13F17B0147 13F17C0176 13F17C0419 13F17E0464 13F17F0039 13F17F0498 13F17F0609 13F17F0789 13F17G02…Lot Numbers: 13F17B0147 13F17C0176 13F17C0419 13F17E0464 13F17F0039 13F17F0498 13F17F0609 13F17F0789 13F17G0250 13F17J0076 13F17K0413 13F17K0414 13F17K0415 13F17K0416 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2012-2018%22
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