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.
Recall
- Recall Number
- Z-1639-2009
- Event Number
- 51898
- Firm
- Aspen Surgical Products, Inc.
- FEI Number
- 3002750084
- Product Code
- GCY
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- April 13, 2009
- Posted
- May 22, 2009
- Terminated
- November 23, 2009
- Address
- 6945 Southbelt Dr Se, Caledonia, MI, 49316-7664
Description
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.
An adaptor, which may be required when connecting the drain to an external device, was not included in the package.
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.
Nationwide Distribution -- California, Florida, Georgia, Massachusetts and Missouri.
9 cases of both products