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U.S. Department of Health and Human Services

Class 1 Device Recall Percutaneous Sheath Introducer Kit with ARROWgard Blue (R) Sheath,

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 Class 1 Recall
Percutaneous Sheath Introducer Kit with ARROWgard Blue (R) Sheath,
see related information
Date Posted March 05, 2010
Recall Status1 Terminated on January 18, 2012
Recall Number Z-0784-2010
Recall Event ID 53954
Premarket Notification
510(K) Number
K940079 
Product Classification Introducer, Catheter - Product Code DYB
Product Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte)
Code Information Product number ASK-29803-SJH. Lot numbers RF9044900 and RF9068155
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading, Pennsylvania 19605
For Additional Information Contact Customer Service Department
800-523-8446
Manufacturer Reason
for Recall
Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446.
Quantity in Commerce 65 kits
Distribution The products were shipped to distributors in GA, MD, and VA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = ARROW INTL., INC.
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