FDA Device recall Z-1183-2020
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1
- 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-TG1 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-1183-2020 |
| 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-TG1
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: 23F19A0154 23F19C0273 23F19F0029 23F19G0360 23F19M0226 |
|---|
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-1183-2020%22
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