Centurion Uterine Sound Recalled Due to Incomplete Sterile Package Seals
Centurion Medical Products Corporation is recalling sterile uterine sounds because incomplete seals may compromise sterility. The products were distributed nationwide and in Ghana.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device, which poses a risk of harm (infection) even though specific injuries are not reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of sterile uterine sounds due to a defect in the sterile packaging. The recall is issued because incomplete seals on the sterile package may compromise the sterility of the device.
The affected products are identified by the code 67465 STERILE SIMS UTERINE SOUND (83360) and lot number 2019032790. According to the source text, these products were distributed nationwide in the United States and in Ghana.
Healthcare providers and consumers should stop using the affected uterine sounds and contact Centurion Medical Products Corporation for instructions on how to return or dispose of the products. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Centurion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790
- Manufacturer
- Centurion Medical Products Corporation
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 (1)
- 67465 STERILE SIMS UTERINE SOUND (83360) 2019032790
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Centurion Medical Products Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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