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

FDA device recall Z-1639-2009 · posted 2009-05-22 · Terminated

Recall details

Recalling firm

Aspen Surgical Products, Inc.

Reason for recall

An adaptor, which may be required when connecting the drain to an external device, was not included in the package.

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.

Root cause

Process change control

Status

Terminated

Product code

GCY

Quantity affected

9 cases of both products

Distribution

Nationwide Distribution -- California, Florida, Georgia, Massachusetts and Missouri.

Date initiated

2009-04-13

Date posted

2009-05-22

Date terminated

2009-11-23

Location

Caledonia, MI