FDAClass IIFebruary 12, 2020

Centurion-general Surgery Convenience Kits Dyndh1033b recall: Sterility Concern

Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A SDS PROCEDURE PACK DYNDH1110 BIOPSY PACK DYNDH1110 BIOPSY PACK…

Why was Centurion-general Surgery Convenience Kits Dyndh1033b recalled?

Incomplete seals on the sterile package may compromise the sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A SDS PROCEDURE PACK DYNDH1110 BIOPSY PACK DYNDH1110 BIOPSY PACK…
Recalling firm
Centurion Medical Products Corporation
Quantity
N/A
Distribution
Nationwide Foreign: GHANA
Recall date
February 12, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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