FDA Enforcement
Class II
Ongoing
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
Recall: Z-0503-2024
·
Reported December 13, 2023
Enforcement
- Recall Number
- Z-0503-2024
- Event ID
- 93239
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- CooperSurgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 13, 2023
- Initiation Date
- March 31, 2022
- Classification Date
- December 6, 2023
- Address
- 95 Corporate Dr, Trumbull, CT, 06611-1350, United States
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
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
Code Info
UDI-DI:60888937016446 S/N: 313121, 313568
Distribution
Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND
Quantity
169 units