Recall Z-3189-2024 ยท HHM Sound, Uterine
CooperSurgical, Inc.
Stainless Steel Sims Uterine Sound, Part Number 64-601
| Date | Sep 20, 2024 (initiated Jul 31, 2024) |
| Status | Open, Classified |
| Reason | During the manufacturing process the devices were laser-marked with the incorrect part number. |
| Root cause | Process control |
| Action | An URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE notification letter dated 7/31/24 was sent to customers. Actions to be Taken: For CUSTOMERS and DISTRIBUTORS: " Inspect your inventory for any of this Product. Product Number and other information can be found on the box and package labeling. " Please complete the included Customer Acknowledgment Form and send it via email to Recall@coopersurgical.com to complete this action. For CUSTOMERS: " If your clinic or health system has multiple locations, and you wish to report for multiple physical locations, please indicate which physical locations in t |
| Quantity | 657 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.