FDA-Device2020-06-17Class II
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.
Arrow International Inc
Hazard
Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
Sold states
US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG.
Affected count
109 eaches (US), 23,021 (OUS)
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2288-2020Don't want to check this manually?
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