Recall Z-1727-2015
CooperSurgical, Inc. · initiated May 18, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Serial Numbers: 020015;020021;020023; 020043;020051
Reason for recall
Design of device may expose user to injury to fingers or body parts
FDA-determined cause: Device Design
Action taken
CooperSurgical initiated the recall on May 18, 2015 via Fedex with confirmed delivery receipt. The letter identified the affected product and asked users to discontinue use and complete the Acknowledgement and Receipt Form to schedule a replacement. Questions contact 203.601.5200.
Details
- Recall number
- Z-1727-2015
- Initiated
- May 18, 2015
- Posted by FDA
- June 8, 2015
- Terminated
- August 7, 2015
- Product code
- LKF – Cannula, Manipulator/Injector, Uterine
- Quantity
- 5 units
- Distribution
- Distributed in the states of CA, IL, NC, and NY.
- Recalling firm
- CooperSurgical, Inc., Trumbull, CT