Z-0503-2024 Class II Ongoing
FDA device recall Z-0503-2024 was initiated by CooperSurgical, Inc. on Mar 31, 2022 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 169 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 13, 2023
- Initiation Date
- Mar 31, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0503-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026