Centurion Medical Recalls Sterile Nail Nippers Due to Compromised Seal
Centurion Medical Products Corporation is recalling sterile nail nippers because the sterile barrier pouch seal is compromised, potentially affecting sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device with a compromised sterile barrier, which poses a risk of infection (risk-of-harm product) but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling the Sterile Nail Nipper, Barrel Spring (I68400), Sterile. The recall is due to a compromised seal on the sterile barrier pouch. This defect may compromise the sterility of the device.
The affected product is identified by Lot 2018121101 with an expiration date of 2023-11-30. The product was distributed nationwide in the United States.
Consumers and healthcare facilities should stop using the affected nail nippers and contact Centurion Medical Products Corporation for further instructions or a replacement.
The recalled product
- Product
- Sterile Nail Nipper, Barrel Spring (I68400), Sterile
- 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 (2)
- Lot 2018121101
- exp 2023-11-30
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →Related recalls
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