Recall Z-2288-2020— Arrow International Inc

Name: FDA recall Z-2288-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-08

Class II · Ongoing

Class II FDA medical device recall by Arrow International Inc, initiated 2020-05-08. It names one FDA 510(k) clearance: K140110. 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.. Reason: Nine complaints reported that the rotatable collar on the filter had detached, causing a leak..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Ongoing
Initiated: 2020-05-08
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K140110 — FLEXTIP PLUS EPIDURAL CATHETER; FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SETTeleflex, Inc.·cleared 2015-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.