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U.S. Department of Health and Human Services

Class 2 Device Recall Scanlan MobinUddin Vein Holder

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  Class 2 Device Recall Scanlan MobinUddin Vein Holder see related information
Date Initiated by Firm February 19, 2007
Date Posted April 03, 2007
Recall Status1 Terminated 3 on June 27, 2007
Recall Number Z-0701-2007
Recall Event ID 37596
Product Classification Vein Holder - Product Code KDC
Product SCANLAN International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog #1001-761, Lot AZ115806.
Code Information Lot AZ115806.
Recalling Firm/
Manufacturer		 Scanlan International Inc
1 Scanlan Plz
Saint Paul MN 55107-1639
Manufacturer Reason
for Recall		 Incorrectly assembled by manufacturer
FDA Determined
Cause 2		 Other
Action The consignees were notified of the product recall by letter dated February 19, 2007. Consignees were asked to return product to the manufacturer and replacement product is being offered.
Quantity in Commerce 35 units domestically ( 70 units to OUS)
Distribution Worldwide distribution --- USA including states of IN, MO and country of Japan
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.
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