CooperSurgical, Inc. Recall 93239
Description: Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -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: 61-3005
CooperSurgical, Inc. Recall 93239 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0502-2024 |
| Event ID | 93239 |
| Event Description | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -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: 61-3005 |
| Product Type | Devices |
| Distribution | Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND |
| Quantity | 73 units |
| Recall 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 |
| Device Classification | 20231213 |
| Device Code Info | UDI-DI: 60888937016408 SN: 312868 |
| Center Classification Date | 20231206 |
| Recall Initiation Date | 20220331 |
| Recalling Firm | CooperSurgical, Inc. |
| Initial Notification | Letter |
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