Centurion Skin Prep Tray Recalled for Incomplete Sterile Package Seals
Centurion Medical Products Corporation is recalling Skin Prep Trays due to incomplete seals on the sterile package, which may compromise 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 is classified as FDA Class II. The hazard involves a potential compromise of sterility, which is a risk-of-harm scenario where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Centurion Medical Products Corporation is recalling the Centurion-Skin Prep Tray (DYNDP1015) because incomplete seals on the sterile package may compromise the sterility of the product. The recall is classified as Class II by the U.S. Food and Drug Administration.
The affected product is identified by the lot code DYNDP1015 SKIN PREP TRAY 2019032290. The product was distributed nationwide and in Ghana.
Consumers and healthcare facilities should stop using the recalled product and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Centurion-Skin Prep Tray DYNDP1015 SKIN PREP TRAY
- Manufacturer
- Centurion Medical Products Corporation
- Hazard
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)
- Product-Lot Code: DYNDP1015 SKIN PREP TRAY 2019032290
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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