Recall Z-1638-2009 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Aspen Surgical Products, Inc.
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.
| Date | May 22, 2009 (initiated Apr 13, 2009) |
| Status | Terminated |
| Reason | An adaptor, which may be required when connecting the drain to an external device, was not included in the package. |
| Root cause | 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 | 9 cases of both products |
| Distribution | Nationwide Distribution -- California, Florida, Georgia, Massachusetts and Missouri. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.