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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Arrow International Inc
- Reason for Recall:
- Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Distribution:
Distributed in: US, CA, FL, MT, AT, AU, DE, ES, FR, JP, SG
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2288-2020
Related Recalls
Reports have been received regarding open seals on the packaging.
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
ARROW INTERNATIONAL
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
ARROW INTERNATIONAL
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.