Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an op
FDA device recall Z-0439-2013 · posted 2012-11-26 · Terminated
Recall details
- Recalling firm
- Cooper Surgical, Inc.
- 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 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LKF
- Quantity affected
- 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 Arabi
- Date initiated
- 2012-10-31
- Date posted
- 2012-11-26
- Date terminated
- 2014-03-04
- Location
- Trumbull, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI (K932115) | Blairden Precision Instruments, Inc. | 1994-06-24 |