Centurion Skin Prep Kits Recalled for Incomplete Seals
Centurion Medical Products is recalling 108 units of Skin Prep Kits due to incomplete seals that may compromise sterility.
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 involves a risk-of-harm product (compromised sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling 108 units of Skin Prep Kits, specifically the SB1280 Skin Scrub Kit and SB1525 Vaginal Prep Tray. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the products.
The affected products were distributed nationwide and in Ghana. The specific lot numbers involved are 2018112690 for the SB1280 Skin Scrub Kit and 2018103190 for the SB1525 Vaginal Prep Tray.
Consumers and healthcare facilities should stop using these products and contact Centurion Medical Products Corporation for instructions on return or replacement.
The recalled product
- Product
- Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Prep
- Hazard
- Affected units
- 108
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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