Recall Z-2288-2020 ยท BSO Catheter, Conduction, Anesthetic
Arrow International Inc
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
| Date | May 8, 2020 |
| Status | Open, Classified |
| Reason | Nine complaints reported that the rotatable collar on the filter had detached, causing a leak. |
| Root cause | Under Investigation by firm |
| Action | On May 8, 2020, the firm distributed "Urgent Medical Device Recall" letters to affected customers. The letter informed customers that the product was being recalled due to complaints reporting that the rotatable collar on the filter had detached, causing a leak. If a leak presents during use, an alternative filter may be required, or the catheter may need to be removed and replaced with a new kit. Customers are asked to take the following actions: 1. If you have affected stock, immediately identify product, discontinue use and quarantine any products with the product codes and lot numbers li |
| Quantity | 109 eaches (US), 23,021 (OUS) |
| Distribution | US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET Teleflex, Inc., Mar 27, 2015 |