Centurion Medical Recalls Skin Prep Trays Due to Incomplete Seals
Centurion Medical Products Corporation is recalling specific lots of sterile skin prep trays because incomplete seals 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 involves a risk-of-harm product (sterile medical device) where the defect (incomplete seals) may compromise sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of Centurion-Skin Prep Trays, including the SP1180 Dry Prep Set, SP200 Skin Scrub Tray, and SP415 Sterile Gauze Sponge. The recall was initiated because incomplete seals on the sterile packages may compromise the sterility of the products.
The affected products were distributed nationwide and to Ghana. The specific lot numbers involved are 2019032690 for the SP1180, 2019051390 for the SP200, and 2019011090 and 2018120390 for the SP415.
Healthcare providers and consumers should stop using these products and contact Centurion Medical Products Corporation for further instructions or a refund.
The recalled product
- Product
- Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE SPONGE
- 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 (1)
- 2018120390
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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