Recall Z-1830-2015— Cook Inc.

Name: FDA recall Z-1830-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-14

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2015-05-14, terminated 2016-09-12. It names one FDA 510(k) clearance: K910914. Product: LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.. Reason: Includes Information not stated in the intended use..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-05-14
Terminated: 2016-09-12
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K910914 — SURGICAL TISSUE POUCHCook Urological, Inc.·cleared 1991-03-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

Reason for recall

Includes Information not stated in the intended use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.