Reported Jun 17, 2020 · Ongoing

Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA…

Arrow International Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607

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.

Lot codes and dates: Lots(Dist'd in US) 23F19A0260 23F19M0224 23F19E0120 23F19L0014 23F19B0184 (Dist'd OUS)
71F19M0710
71F18K1579
71F18F1429
71F18J2111
71F20A1078
71F20A1614
71F19E2019
71F19L0269
71F19L2068
71F19K1049
71F19K2042
71F19L0977
71F19M1319
71F20A0805
71F20A0812
71F20A0813
71F19J0604
71F19K1653
71F19K2501
71F19M0326
71F20A1819
71F20A2040
71F20A0044
71F19K2043
71F19L0359
Amount recalled: 109 eaches (US), 23,021 (OUS)

Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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72 in total.