Centurion circumcision kits distributed without the required sterilization process
Medline is recalling one lot of Centurion Circumcision Kits that was distributed without undergoing the required sterilization process and is therefore not sterile. 640 kits are affected.
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: FDA Class II recall of a surgical kit that never underwent sterilization, a risk of harm with no injuries reported in the source.
Plain-English summary
Medline is recalling the CENTURION Circumcision Kit, Medline kit number/SKU CIT7050F, lot number 25KLA002, UDI/DI each 10198459536656. The action covers 640 kits.
One lot of these sterile circumcision kits was distributed without the required sterilization process and is therefore not sterile. The FDA classified the action as Class II.
Distribution was within the United States, in South Carolina. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the SKU, UDI and lot number above, quarantine it, and follow the instructions issued by Medline.
The recalled product
- Product
- CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
- Manufacturer
- Medline Industries, LP
- Affected units
- 640
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 (4)
- Medline Kit Number/SKU CIT7050F
- UDI/DI each 10198459536656
- UDI/DI case 40198459536657
- Lot Number 25KLA002
Distribution
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