Z-1638-2009

Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4...

Name: Z-1638-2009 Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4...
Creator: Aspen Surgical Products, Inc.
Published: 2009-04-13
License: https://open.fda.gov/license/

Aspen Surgical Products, Inc. / initiated 2009-04-13 / Terminated / root cause: packaging

FDA source

Aspen Surgical Products, Inc. began a recall of 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... on 2009-04-13. The reason FDA records is "An adaptor, which may be required when connecting the drain to an external device, was not included in the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1638-2009
Status: Terminated
Initiated: 2009-04-13
Posted: 2009-05-22
Terminated: 2009-11-23
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.
Product code: GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Reason for recall: An adaptor, which may be required when connecting the drain to an external device, was not included in the package.
Root cause tag: packaging
FDA 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 in commerce: 9 cases of both products
Distribution: Nationwide Distribution -- California, Florida, Georgia, Massachusetts and Missouri.
Product codes and lots: Lot Number 2014-02-13.

Product code GCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)