Recall Z-0114-2015— Arrow International Inc
Class II · Terminated
Class II FDA medical device recall by Arrow International Inc, initiated 2014-09-15, terminated 2015-12-18. It names one FDA 510(k) clearance: K001587. Product: ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit. 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..
- Recalling firm
- Arrow International Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-15
- Terminated
- 2015-12-18
- Firm location
- Reading, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.