Covidien LLC: Medical Device Recall in 2015 - (Recall #: Z-1599-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.

Product Classification:

Class II

Date Initiated: April 28, 2015

Date Posted: May 20, 2015

Recall Number: Z-1599-2015

Event ID: 71138

Reason for Recall:

Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.

Status: Terminated

Product Quantity: 1661 units

Code Information:

Model no. SP-101, Lots, 35766, 36191, 36192, 36617, 36618, 37621, 37622, 37399, 37400, 38263, 38286, 38407, 38417, 38756, 38863, 38864, 39113, 39336, 39378, 39670, 39739, 39848 and 40075.; Model no. VS-301, Lots 34193, 35585, 37007, 38804, 39111, 39123, 39469 and 40160; Model no. VS-402, Lots 39970, 39971, 39972, 39973, 40067, 40069, 40187, 40243, 40271 and 40272.

Distribution Pattern:

Worldwide distribution. No U.S. accounts; Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Switzerland, UAE and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated