ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
FDA device recall Z-0114-2015 · posted 2014-10-22 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 300
- Distribution
- US Distribution in Utah only.
- Date initiated
- 2014-09-15
- Date posted
- 2014-10-22
- Date terminated
- 2015-12-18
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 19 GA PLASTIC REINFORCED EPIDURAL CATHETER (K001587) | Arrow Intl., Inc. | 2000-07-12 |