Centurion Medical Suture Trays Recalled for Incomplete Sterile Package Seals
Centurion Medical Products Corporation is recalling various suture and laceration trays because incomplete seals on the sterile packages 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, and the hazard involves compromised sterility of medical devices, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling multiple models of suture trays, laceration trays, and surgical sets. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the medical devices.
The affected products include a wide range of suture and laceration trays, such as the SUT10140 Suture Tray and SUT10290 Laceration Tray, distributed nationwide and in Ghana. The source text does not specify the total number of units affected or the specific dates of distribution.
Healthcare facilities and consumers should stop using these products and contact Centurion Medical Products Corporation for further instructions on how to return or dispose of the affected trays.
The recalled product
- Product
- Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING TRAY SUT10770 DEBRIDEMENT/SUTURE SET SUT10795 PORT IMPLANT SET SUT11035 SUTURE TRAY SUT11065 LACERATION TRAY SUT1113A SUTURING SET SUT11145 SNAGFREE SUTURE SET W/SURGICAL INST.…
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Trays
- Hazard
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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