FDA Device recall Z-1184-2020
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH
- FDA Device
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH 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-1184-2020 |
| 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
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH
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: 13F18L0892 13F19C0478 13F19E0433 13F19K0051 13F19B0588 13F19D0327 13F19H0209 13F19L0079 |
|---|
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-1184-2020%22
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