FDA Device recall Z-1178-2020
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05500-BID
- 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-05500-BID 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-1178-2020 |
| 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-05500-BID
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: 23F19E0337 23F19J0065 23F19K0100 23F19L0218 23F19H0048 23F19J0314 23F19K0303 23F19M0007 |
|---|
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-1178-2020%22
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