Centurion Medical Products Recalls Sterile Surgery Kits Due to Seal Defects
Centurion Medical Products Corporation is recalling specific lots of sterile surgery kits because incomplete seals 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 device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of Centurion-General Surgery Convenience Kits, including biopsy packs, lumbar puncture trays, and ultrasound kits. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the contents.
The affected products were distributed nationwide and in Ghana. The recall covers specific lot numbers for various kits, including the Subclavian On/Off Kit, SDS Procedure Pack, and Holston Myelogram Pack.
Consumers and healthcare facilities should stop using the affected products and contact Centurion Medical Products Corporation for further instructions.
The recalled product
- Product
- Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A SDS PROCEDURE PACK DYNDH1110 BIOPSY PACK DYNDH1110 BIOPSY PACK DYNDH1110 BIOPSY PACK DYNDH1114 BIOPSY TRAY DYNDH1131 WDC ULTRASOUND KIT DYNDH1227A HOLSTON MYELOGRAM PACK DYNDH1227A…
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- 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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