Stainless Steel Sims Uterine Sound Recalled for Incorrect Part Number
CooperSurgical, Inc. is recalling the Stainless Steel Sims Uterine Sound (Part Number 64-601) because some units were laser-marked with incorrect part numbers during manufacturing. No injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device with a labeling error (incorrect part number marking). No injuries or illnesses have been reported. The incorrect labeling is a minor manufacturing defect that could affect device identification but poses a theoretical rather than confirmed patient safety risk.
Plain-English summary
CooperSurgical, Inc. is recalling the Stainless Steel Sims Uterine Sound, Part Number 64-601, a surgical instrument used in gynecological procedures. The company identified that 657 units were laser-marked with incorrect part numbers during the manufacturing process.
The incorrect labeling could lead to confusion when selecting the correct instrument for surgical use, creating a potential patient safety risk. The devices were distributed worldwide, including throughout the United States and to Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, and Sweden.
No injuries or adverse events have been reported to date. Healthcare facilities and providers should immediately check their inventory of the Stainless Steel Sims Uterine Sound (Part Number 64-601) to verify the laser-marked part number matches the actual product. Any units with discrepancies should be removed from use and returned to CooperSurgical, Inc. for verification and replacement.
The recalled product
- Product
- Stainless Steel Sims Uterine Sound, Part Number 64-601
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- mis-labeling
- incorrect-part-number
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00888937017779
- Part Numbers: 64-600
Distribution
Distributed nationwide across the United States.
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