Centurion Laceration Tray Kits Recalled for Potential Sterile Packaging Compromise
Centurion Medical Products is recalling Laceration Tray Kits because sterile packaging may be compromised, posing a risk of infection.
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 medical device where sterile packaging may be compromised, creating a risk of infection (harm) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Centurion Medical Products Corporation is recalling 3,804 Laceration Tray Kits (Kit Code: SUT18370) due to a potential compromise in the sterile packaging. The kits are used for laceration repairs for the general population. The affected lot is # 2019013190, with an expiration date of 4/30/2021.
The recall was initiated because the sterile packaging may be compromised, which could lead to a loss of sterility. The products were distributed nationwide in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, and WI.
Consumers and healthcare providers should stop using the affected kits and contact Centurion Medical Products Corporation for further instructions or a refund.
The recalled product
- Product
- LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population.
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- Affected units
- 3,804
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 # 2019013190 Exp: 4/30/2021
Distribution
Part of a larger recall action
This product is one of 13 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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