Recall Z-1727-2015— CooperSurgical, Inc.

Name: FDA recall Z-1727-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-18

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2015-05-18, terminated 2015-08-07. It names one FDA 510(k) clearance: K141523. Product: Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS. Reason: Design of device may expose user to injury to fingers or body parts.

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-05-18
Terminated: 2015-08-07
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K141523 — ALLY UPSCooperSurgical, Inc.·cleared 2014-11-25

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

Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS

Reason for recall

Design of device may expose user to injury to fingers or body parts

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