Recall Z-0114-2015 ยท CAZ Anesthesia Conduction Kit
Arrow International Inc
ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
| Date | Oct 22, 2014 (initiated Sep 15, 2014) |
| Status | Terminated |
| Reason | 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 | Labeling mix-ups |
| 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. |
| Quantity | 300 |
| Distribution | US Distribution in Utah only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001587 | 19 GA PLASTIC REINFORCED EPIDURAL CATHETER Arrow Intl., Inc., Jul 12, 2000 |