Date Initiated by Firm |
June 07, 2010 |
Date Posted |
August 25, 2010 |
Recall Status1 |
Terminated 3 on September 29, 2012 |
Recall Number |
Z-2274-2010 |
Recall Event ID |
55933 |
510(K)Number |
K781846
|
Product Classification |
introducer - Product Code KGZ
|
Product |
Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801 |
Code Information |
Lot numbers RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262 |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Road Reading PA 19605
|
For Additional Information Contact |
610-378-0131
|
Manufacturer Reason for Recall |
Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed.
|
FDA Determined Cause 2 |
Process change control |
Action |
June 7, 2010 Notification letter to customer instructed them to return the product to Arrow. Arrow will destroy the returned product. |
Quantity in Commerce |
3000 kits |
Distribution |
All affected product was distributed to one foreign consignee: Arrow Japan Ltd. |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
510(K) Database |
510(K)s with Product Code = KGZ and Original Applicant = ARROW INTL., INC.
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