FlexTip Plus Epidural Catheterization Set — Class II medical device recall Z-1201-2020
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-1201-2020 |
|---|---|
| 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 | 71F19A0552, 71F19A1876, 71F19A2686, 71F19A2926, 71F19B0499, 71F19B1222, 71F19B2079, 71F19B2664, 71F19B2849, 71F19C0531, 71F19C1329, 71F19C2027, 71F19C2239, 71F19C2723, 71F19C2866, 71F19D0056, 71F19D0839, 71F19D1511, 71F19D1772, 71F19D2237, 71F19D2580, 71F19E0587, 71F19E0689, 71F19E1636, 71F19E2838, 71F19E3183, 71F19F0256, 71F19F0481, 71F19F0794, 71F19F1426, 71F19F2006, 71F19G0494, 71F19G1028, 71F19G1720, 71F19G2237, 71F19G2837, 71F19G2970, 71F19H1056, 71F19H1236, 71F19H1300 and 11 more |
Product
FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B
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-1201-2020. 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.