Arrow International Inc recalls Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TA

Recalled June 17, 2020 · FDA recall Z-2288-2020 · Arrow International

Hazard

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

Units

109 eaches (US), 23,021 (OUS)

Sold at

US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG.

Description

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

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.

Manufacturer(s)

Arrow International Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →