FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1638-2009
- Recalling firm
- Aspen Surgical Products, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-04-13
- Posted
- 2009-05-22
- Terminated
- 2009-11-23
- 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.
- Lot, serial or model codes
- Lot Number 2014-02-13.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCY
- Firm FEI
- 3002750084
- Firm city
- Caledonia
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28