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Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A SDS PROC...

FDA Recall #Z-1052-2020 — Class II — December 11, 2019

Recall #Z-1052-2020 Date: December 11, 2019 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Incomplete seals on the sterile package may compromise the sterility

Recalling Firm

Centurion Medical Products Corporation — Williamston, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

N/A

Distribution

Nationwide Foreign: GHANA

Code Information

Lot Numbers: DYNDH1033B SUBCLAVIAN ON/OFF KIT 2019061080 DYNDH1090A SDS PROCEDURE PACK 2019021990 DYNDH1110 BIOPSY PACK 2019032990 DYNDH1110 BIOPSY PACK 2019011590 DYNDH1110 BIOPSY PACK 2018092590 DYNDH1114 BIOPSY TRAY 2018111290 DYNDH1131 WDC ULTRASOUND KIT 2019030690 DYNDH1227A HOLSTON MYELOGRAM PACK 2019061090 DYNDH1227A HOLSTON MYELOGRAM PACK 2019022790 DYNDH1265 MYELOGRAM TRAY 2018101990 DYNDH1272 LUMBAR PUNCTURE TRAY 2019020590 DYNDH1281A PARA/THORA ULTRASOUND 2019040180 DYNDH1285A BIOPSY ULTRASOUND 2019051380 DYNDH1321 LUMBAR PUNCTURE TRAY 2019011590 DYNDH1349 ARTHROGRAM TRAY 2018121390 DYNDH1359 DIAGNOSTIC TRAY 2019040290 DYNDH1397 GENERAL ASPIRATION TRAY - CHOICE 2019031880 DYNDH1399 ARTHROGRAM TRAY 2019042290

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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