Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysteroson
FDA device recall Z-0502-2024 · posted 2023-12-06 · Open, Classified
Recall details
- Recalling firm
- CooperSurgical, Inc.
- 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
- 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.
- Root cause
- Component design/selection
- Status
- Open, Classified
- Product code
- LKF
- Quantity affected
- 73 units
- Distribution
- Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND
- Date initiated
- 2022-03-31
- Date posted
- 2023-12-06
- Location
- Trumbull, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (K961752) | Ackrad Laboratories | 1996-08-08 |