Centurion Medical Laceration Trays Recalled for Incomplete Sterile Package Seals
Centurion Medical Products Corporation is recalling various laceration and medical trays due to incomplete seals on sterile packages that 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 devices) where the hazard is a potential loss of sterility, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of laceration trays, pain kits, and other medical trays. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the contents.
The affected products include various laceration trays, a pain kit, a vaginal delivery tray, PICC insertion kits, an arthrogram tray, suturing sets, and suture set packs. The distribution pattern is listed as nationwide and foreign (Ghana).
Consumers and healthcare facilities should check their inventory for the specific lot numbers listed in the recall notice. If the products are found, they should stop using them and contact Centurion Medical Products Corporation for instructions on return or disposal.
The recalled product
- Product
- Centurion- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1223A LACERATION TRAY DYNDL1295B KIT,PAIN DYNDL1436A LACERATION TRAY DYNDL1436A LACERATION TRAY DYNDL1600B RCHSD CVP TRAY DYNDL1606A VAGINAL DELIVERY TRAY…
- 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.
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