Z-0503-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- March 31, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 169 units
Product Description
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes Model: 61-4005
Reason for Recall
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
Distribution Pattern
Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND
Code Information
UDI-DI:60888937016446 S/N: 313121, 313568