Recall Z-0503-2024 ยท LKF Cannula, Manipulator/Injector, Uterine
CooperSurgical, Inc.
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
| Date | Dec 6, 2023 (initiated Mar 31, 2022) |
| Status | Open, Classified |
| 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 |
| Root cause | Component design/selection |
| Action | CooperSurgical issued Urgent Medical Device Safety Notice dated March 22, 2023 via UPS Certified Delivery Mail. Letter states reason for recall, health risk and action to take:Our records indicate that you may have purchased the affected Product from CooperSurgical. Please inspect stock and complete the attached Acknowledgement and Receipt Form. Once completed please return the form to CooperSurgical to acknowledge receipt of the notice. If you do not have affected Product in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document r |
| Quantity | 169 units |
| Distribution | Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013972 | H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 Ackard Laboratories, Dec 17, 2001 |