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U.S. Department of Health and Human Services

Class 2 Device Recall Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Cat

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  Class 2 Device Recall Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Cat see related information
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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