Recall Z-0602-2016 ยท PFJ Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
Ethicon, Inc.
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
| Date | Jan 6, 2016 (initiated Dec 3, 2015) |
| Status | Terminated |
| Reason | Stability data does not substantiate the labeled two-year shelf life of affected product. |
| Root cause | Device Design |
| Action | Ethicon, Inc. sent "Urgent: Medical Device Recall (REMOVAL)" notifications and Business Reply Forms dated 12/3/2015 on same date via UPS Next Day Mail to its customers. The notification informed the customers of the issue with the product; how to identify affected product and action required. The customers were instructed to examine their inventory immediately to determine if they have affected product on hand and quarantine the affected product(s); remove the affected product and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facil |
| Quantity | 96,124 units |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: India, Belgium, Argentina, Mexico, Brazil, Canada, Colombia, Ecuador, Singapore, Aruba and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.