—#130107

Product

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

FDA product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K001587
Affected lot / code info: Catalog No. ASK-05501-AFH1 Lot Number 23F13K0969

Why it was recalled

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: US Distribution in Utah only.

Timeline

Recall initiated: 2014-09-15
Posted by FDA: 2014-10-22
Terminated: 2015-12-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130107. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.