| | Class 2 Recall
Cooper Surgical Advincula Arch |  |
| Date Posted |
November 26, 2012 |
| Recall Number |
Z-0440-2013 |
| Product |
Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle
Ref: UMH750
The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy |
| Code Information |
Arch handles with a serial number less
than 1204001, or between 1111001 0 and 1111 0069
|
Recalling Firm/
Manufacturer |
Cooper Surgical, Inc.
95 Corporate Dr
Trumbull, Connecticut 06611-1350 |
| For Additional Information Contact |
Customer Service
203-601-9818
|
Reason for
Recall |
Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle
|
| Action |
CooperSurgical issued notification on October 31, 2012, to all affected customers Fed X . The notification identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return units for replacement. Customers with questions should contact Customer Serivce at 1-203-601-9818 or 800-243-2974. Customers were asked to fill out the attached Replacement of Recalled Product Form and fax it to 1-800-262-0105.
For questions regarding this recall call 203-601-9818. |
| Quantity in Commerce |
1215 total |
| Distribution |
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Czech Republic, Germany, Italy, Spain, France, United Kingdom, Japan, New Zealand, South Korea, Saudi Arabia, Sweden, Singapore, Slovenia, and Taiwan. |
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