CooperSurgical recalls stainless steel Sims Uterine Sound (part 64-6:601) due to incorrect laser marking during manufacturing. Affected units may have wrong part numbers and should be checked.
During the manufacturing process the devices were laser-marked with the incorrect part number.
CooperSurgical is recalling a specific model of uterine sound because it was laser-marked with the wrong part number during production. This could lead to confusion about the product's identity and potentially cause errors in medical use.
The device was laser-marked with an incorrect part number during manufacturing. This could cause confusion about which model is being used, potentially leading to errors in medical procedures if the wrong device is selected.
Healthcare providers using the specific model of uterine sound may be affected. Patients undergoing procedures with this device could be at risk if the wrong part is used.
Check for the part number 64-601 on the device. The UDI-DI code 00888937017779 is also associated with this model. This product was sold with part numbers 64-600 and 64-601.
Verify the part number on the device; affected units have part number 64-601.
The devices were laser-marked with the incorrect part number during manufacturing.
Check for part number 64-601 on the device or UDI-DI code 00888937017779.
The recall does not require immediate action; check the part number to confirm if it's affected.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-3189-2024 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-3189-2024 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
