Medical device recalls Moderate risk

Centurion Medical Products Corporation recalls Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A SDS PROCEDURE PACK DYNDH1110 BIO…

Recall date
December 11, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1052-2020
FDA classification
Class II
Brand / firm
Centurion Medical Products Corporation
Sold / distributed
Nationwide Foreign: GHANA

Why it was recalled

Incomplete seals on the sterile package may compromise the sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 HOLSTON MYELOGRAM PACK DYNDH1265 MYELOGRAM TRAY DYNDH1272 LUMBAR PUNCTURE TRAY DYNDH1281A PARA/THORA ULTRASOUND DYNDH1285A BIOPSY ULTRASOUND DYNDH1321 LUMBAR PUNCTURE TRAY DYNDH1349 ARTHROGRAM TRAY DYNDH1359 DIAGNOSTIC TRAY DYNDH1397 GENERAL ASPIRATION TRAY - CHOICE DYNDH1399 ARTHROGRAM TRAY

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