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Terminated

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.

FDA Recall Z-1638-2009 · Posted 2009-05-22

Recall StatusTerminated
Product CodeGCY
Date Initiated2009-04-13
Date Terminated2009-11-23
Product Quantity9 cases of both products

Reason for Recall

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

Firm 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.

Root Cause

Process change control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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