Centurion Medical Recalls Suture Trays Due to Sterile Packaging Concerns
Centurion Medical Products is recalling 48 SNAG FREE SUTURE TRAY kits because sterile packaging may be compromised, posing a risk of infection.
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 medical device where sterile packaging may be compromised, creating a risk of infection (harm) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling 48 units of the SNAG FREE SUTURE TRAY (Kit Code: SUT14355). The recall was initiated due to a potential for the sterile packaging to be compromised. The product is used for laceration repairs for the general population.
The affected units are identified by Lot # 2019041290 with an expiration date of 3/31/2024. These 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 suture trays and contact Centurion Medical Products Corporation for further instructions or a refund.
The recalled product
- Product
- SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general population.
- Manufacturer
- Centurion Medical Products Corporation
- Hazard
- Affected units
- 48
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 # 2019041290 Exp: 3/31/2024
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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