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U.S. Department of Health and Human Services

Class 3 Device Recall Arrowgard Blue Two Lumen CVC Super Kit

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  Class 3 Device Recall Arrowgard Blue Two Lumen CVC Super Kit see related information
Date Initiated by Firm September 27, 2004
Date Posted October 28, 2004
Recall Status1 Terminated 3 on November 30, 2004
Recall Number Z-0059-05
Recall Event ID 30115
510(K)Number K993691  
Product Classification Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
Product Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+ard Blue Plus Catheters. The plus indicates that the line extension clamps are attached to the catheters.
Code Information Lot number RF4066579
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Jody Cadd
610-378-0131 Ext. 3318
Manufacturer Reason
for Recall		 Labeling error. Kits contains the correct components for AK-42802-SK but may have a package label indicating that it is product number AK-22802-SK
FDA Determined
Cause 2		 Other
Action The recalling firm issued a recall letter dated 9/27/04 to their accounts informing them of the problem and the need to return the product.
Quantity in Commerce 290 kits
Distribution The products were shipped to distributors in KS and VA, medical facilities in AR, FL, and GA, and a sales representative in FL.
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 = FOZ and Original Applicant = ARROW INTL., INC.
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