Centurion Suture Tray Recalled Due to Incomplete Sterile Package Seals
Centurion Medical Products is recalling Suture Trays because incomplete seals on the sterile package 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 medical device where compromised sterility poses a risk of harm (infection), but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Centurion Medical Products Corporation is recalling the Centurion-Suture Tray (DYNDR1210A) due to a defect in the sterile packaging. The recall was initiated because incomplete seals on the sterile package may compromise the sterility of the medical device.
The affected product is the Centurion-Suture Tray, identified by the product-lot code DYNDR1210A SUTURING TRAY 2019031290. The distribution pattern for this recall is listed as Nationwide and Foreign: GHANA.
Consumers and healthcare facilities should stop using the affected suture trays and contact Centurion Medical Products Corporation for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Centurion-Suture Tray DYNDR1210A SUTURING TRAY
- 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)
- Product-Lot Code: DYNDR1210A SUTURING TRAY 2019031290
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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