FDA Device recall Z-1197-2020
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04
- FDA Device
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04 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-1197-2020 |
| 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
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04
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: 71F19B0678 71F19C1428 71F19E1149 71F19G0313 71F19J0072 71F19L0492 71F19B2751 71F19D0558 71F19E1781 71F19…Lots: 71F19B0678 71F19C1428 71F19E1149 71F19G0313 71F19J0072 71F19L0492 71F19B2751 71F19D0558 71F19E1781 71F19G2388 71F19J1370 71F19L0493 71F19C0778 71F19D2449 71F19F0737 71F19H1817 71F19K2849 |
|---|
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-1197-2020%22
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