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U.S. Department of Health and Human Services

Class 3 Device Recall Surgidyne SVac round fluted channel silicone drain kit

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  Class 3 Device Recall Surgidyne SVac round fluted channel silicone drain kit see related information
Date Initiated by Firm April 13, 2009
Date Posted May 22, 2009
Recall Status1 Terminated 3 on November 23, 2009
Recall Number Z-1639-2009
Recall Event ID 51898
Product Classification Surgidyne S-Vac round fluted channel silicone drain kit - Product Code GCY
Product Surgidyne S-Vac round fluted channel silicone drain kit, 10 FR, round, full fluted, 4 channel, 28 cm length, 1/8" trocar, contains 10, sterile, 100cc S-Vac silicone bulb evacuator, Sterion Inc., Ham Lake, MN; REF 332263.

The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.
Code Information Lot Numbers: 2014-03-07 and 2014-03-06.
Recalling Firm/
Manufacturer
Aspen Surgical Products, Inc.
6945 Southbelt Dr Se
Caledonia MI 49316-7664
For Additional Information Contact
616-698-7100 Ext. 142
Manufacturer Reason
for Recall
An adaptor, which may be required when connecting the drain to an external device, was not included in the package.
FDA Determined
Cause 2
Process change control
Action An "Urgent Medical Device recall" letter dated April 13, 2009 was issued to consignees via certified mail. The letter described the affected product. and actions for customers. Consignees were instructed to carry out the recall to the retail level and to quarantine and return the product to Aspen Surgical Products, Inc. Consignees were also instructed to complete the enclosed response form and return it via mail, fax or e-mail. Direct questions about the recall by calling Aspen Surgical Products, Inc. at 1-616-698-7100, extension 142 or extension 141.
Quantity in Commerce 9 cases of both products
Distribution Nationwide Distribution -- California, Florida, Georgia, Massachusetts and Missouri.
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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