Recall Z-0502-2024
CooperSurgical, Inc. · initiated March 31, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: UDI-DI: 60888937016408 SN: 312868
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
FDA-determined cause: Component design/selection
Action taken
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 receipt of this Recall Notice. A corrective action has been initiated to ensure this failure does not reoccur. We sincerely apologize for any inconvenience caused by this notice. CooperSurgical is committed to high quality, safe and effective products. Please feel free to reach us at 203-601-5200 ext. 3300 or via email at Recall@coopersurgical.com.
Details
- Recall number
- Z-0502-2024
- Initiated
- March 31, 2022
- Posted by FDA
- December 6, 2023
- Product code
- LKF – Cannula, Manipulator/Injector, Uterine
- Quantity
- 73 units
- Distribution
- Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND
- Recalling firm
- CooperSurgical, Inc., Trumbull, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0503-2024 Class II | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during…Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component… | 03/31/2022Open, Classified |
| Z-0504-2024 Class II | CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For…Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component… | 03/31/2022Open, Classified |