Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4 channel, contains 10, sterile, Sterion Inc., Ham Lake, MN; REF 332187. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.
This recall has been terminated (originally issued May 22, 2009).
- Company
- Aspen Surgical Products, Inc.
- Recall Initiated
- April 13, 2009
- Posted
- May 22, 2009
- Terminated
- November 23, 2009
- Recall Number
- Z-1638-2009
- Quantity
- 9 cases of both products
- Firm Location
- Caledonia, MI
- Official Source
- View on FDA website ↗
Reason for Recall
An adaptor, which may be required when connecting the drain to an external device, was not included in the package.
Distribution
Nationwide Distribution -- California, Florida, Georgia, Massachusetts and Missouri.
Lot / Code Info
Lot Number 2014-02-13.
Root Cause
Process change control
Action Taken
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.