Centurion Irrigation Kit Recalled Due to Incomplete Sterile Package Seals
Centurion Medical Products is recalling 270 irrigation kits because incomplete seals may compromise sterility. The products were distributed nationwide and in Ghana.
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 where compromised sterility poses a risk of harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Centurion Medical Products Corporation is recalling 270 units of the Centurion-Irrigation Kit (IG25STSS), which includes an irrigation gun and valve set with a splashshield. The recall is due to incomplete seals on the sterile package, which may compromise the sterility of the device.
The affected products were distributed nationwide in the United States and in Ghana. The specific lot code for the recalled items is 2019021190.
Consumers should stop using the recalled irrigation kits and contact Centurion Medical Products Corporation for further instructions or a replacement.
The recalled product
- Product
- Centurion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y
- Manufacturer
- Centurion Medical Products Corporation
- Hazard
- Affected units
- 270
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)
- Lot Code: 2019021190
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.
See all 54 products in this recall →Related recalls
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