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U.S. Department of Health and Human Services

Class 2 Device Recall Percutaneous Sheath Introducer (PSI) Arrow Select Kit

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  Class 2 Device Recall Percutaneous Sheath Introducer (PSI) Arrow Select Kit see related information
Date Initiated by Firm December 15, 2009
Date Posted May 05, 2010
Recall Status1 Terminated 3 on July 29, 2011
Recall Number Z-1538-2010
Recall Event ID 54091
510(K)Number K781846  
Product Classification Catheter Accessories - Product Code KGZ
Product Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605

Permits venous access and catheter introduction to the central circulation.
Code Information Catalog number: ASK-09903-CMC, Lot number RF9060715
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Ms Jody Cadd
610-378-0131 Ext. 3318
Manufacturer Reason
for Recall		 Some central venous catheter sets had the incorrect lid stock.
FDA Determined
Cause 2		 Packaging
Action Consignees were notified by an Urgent Medical Device Recall letter on/about 12/15/2009. The letter identified the affected product and stated the reason for the recall. Customers were instructed to immediately check their stock and cease use, distribution, and quarantine affected product. They are also to contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization Number. Customers are to return any affected product along with the Advisory Acknowledgement and Stock Status Form. Arrow will either provide replacement with a similar product or credit customers' accounts. Customer Service can be contacted with questions or for clarification.
Quantity in Commerce 295 kits
Distribution Nationwide Distribution -- MA.
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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