Z-2288-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- May 8, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 109 eaches (US), 23,021 (OUS)
Product Description
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.
Distribution Pattern
US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG.
Code Information
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