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Class 2 Device Recall ARROW Epidural Needle Component |
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Date Initiated by Firm |
January 05, 2015 |
Date Posted |
February 10, 2015 |
Recall Status1 |
Terminated 3 on July 17, 2018 |
Recall Number |
Z-1080-2015 |
Recall Event ID |
70177 |
510(K)Number |
K884552
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Product Classification |
Anesthesia conduction kit - Product Code CAZ
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Product |
ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement. |
Code Information |
Product number AN-05501, Lot numbers: 23F13J0530, RF2108954, RF6127264, RF8045530, RF0021370, RF3014600, RF6127624, RF8070744, RF0035171, RF3026989, RF7031498, RF8083748, RF0050648, RF5084669, RF7043570, RF8096949, RF0075647, RF5094931, RF7088907, RF8123534, RF0092301, RF5106225, RF7090151, RF9015869, RF2021938, RF5118327, RF7102346, RF9030002, RF2044557, RF5120725, RF7113197, RF9071402, RF2058276, RF6081852, RF8018337, RF9098526, RF2083791, RF6092570, RF8020947, and RF9113319. |
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
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Manufacturer Reason for Recall |
The product labeling does not specify the 5 year shelf life of the product.
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FDA Determined Cause 2 |
Labeling design |
Action |
Urgent Medical Device Recall Notifications, dated January 2015, were sent to direct accounts that identified the product, problem, and actions to be taken. Customers were asked to discontinue use and return affected product. |
Quantity in Commerce |
63022 |
Distribution |
Distribution US Nationwide, Canada and Mexico. |
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 and Original Applicant = ARROW INTL., INC.
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