Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit

FDA Recall Z-0114-2015 · Posted 2014-10-22

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeCAZ
Date Initiated2014-09-15
Date Terminated2015-12-18
Product Quantity300

Reason for Recall

Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one Syringe, 10mL, Luer-Slip Loss of Resistance, Glass but contains one Syringe, 10mL, Luer-Lock Loss of Resistance, Glass.

Firm Action

Arrow International sent a Medical Device Advisory Notification dated September 15, 2014, to affected customers notifying them that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component, and requesting they provide this Advisory Notice to all those who need to be aware of it within your organization. Questions were directed to local sales representative or Customer Service at 1-866-246-6990.

Root Cause

Labeling mix-ups

Distribution Pattern

US Distribution in Utah only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K00158719 GA PLASTIC REINFORCED EPIDURAL CATHETERArrow Intl., Inc. · 2000-07-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑