Date Initiated by Firm | September 15, 2014 |
Date Posted | October 22, 2014 |
Recall Status1 |
Terminated 3 on December 18, 2015 |
Recall Number | Z-0114-2015 |
Recall Event ID |
69256 |
510(K)Number | K001587 |
Product Classification |
Anesthesia conduction kit - Product Code CAZ
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Product | ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit |
Code Information |
Catalog No. ASK-05501-AFH1 Lot Number 23F13K0969 |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Road Reading PA 19605
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For Additional Information Contact | Customer Support 610-378-0131 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 300 |
Distribution | US Distribution in Utah only. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CAZ
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