FDA Device recall Z-1175-2020
TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
- FDA Device
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1 by Arrow International, citing there is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1175-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-15 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Arrow International |
| Distribution | AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY |
Product
TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
Reason
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Identifiers
| code_info | Lots: 23F18M0499 23F19F0164 23F19H0109 23F19L0471 23F19C0409 23F19G0535 23F19K0082 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1175-2020%22
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