FlexTip Plus Combined Spinal Epidural Catheterization Kit — Class II medical device recall Z-1184-2020
Terminated recall by Arrow International Inc, reported 2020-02-19, distributed in AK, AR, AZ, CA, CO, CT, FL, GA…. There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits re
| Recall number | Z-1184-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2020-01-15 |
| Classified | 2020-02-13 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2023-03-17 |
| Distributed | 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 |
| Quantity | 343,105 total |
| Lot numbers | 13F18L0892, 13F19B0588, 13F19C0478, 13F19D0327, 13F19E0433, 13F19H0209, 13F19K0051, 13F19L0079 |
Product
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1184-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.