Arrow FlexTip Plus Epidural Kit with NRFit Connector — Class II medical device recall Z-2288-2020
Ongoing recall by Arrow International Inc, reported 2020-06-17, distributed in CA, FL, MT. Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
| Recall number | Z-2288-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2020-05-08 |
| Classified | 2020-06-05 |
| Reported by FDA | 2020-06-17 |
| Distributed | CA, FL, MT |
| Reason classes | packaging, device malfunction |
| Lot numbers | 23F19A0260, 23F19B0184, 23F19E0120, 23F19L0014, 23F19M0224, 71F18F1429, 71F18J2111, 71F18K1579, 71F19E2019, 71F19J0604, 71F19K1049, 71F19K1653, 71F19K2042, 71F19K2043, 71F19K2501, 71F19L0269, 71F19L0359, 71F19L0977, 71F19L2068, 71F19M0326, 71F19M0710, 71F19M1319, 71F20A0044, 71F20A0805, 71F20A0812, 71F20A0813, 71F20A1078, 71F20A1614, 71F20A1819, 71F20A2040 |
Product
Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
Reason for recall
Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
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-2288-2020. 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.