The Recall Desk
HighFDA (Devices)·Z-1052-2020·Announced 2020-02-12

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.

What this means for you

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 HOL

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 →