Recall Z-0440-2013
Cooper Surgical, Inc. · initiated October 31, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Arch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069
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
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0440-2013
- Initiated
- October 31, 2012
- Posted by FDA
- November 26, 2012
- Terminated
- March 4, 2014
- Product code
- LKF – Cannula, Manipulator/Injector, Uterine
- Quantity
- 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.
- Recalling firm
- Cooper Surgical, Inc., Trumbull, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0439-2013 Class II | Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended…Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances… | 10/31/2012Terminated |