FDAClass IIFebruary 12, 2020

Centurion- Dressing Change Kits Dyndc1182b Picc recall: Sterility Concern

Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C CENTRAL LINE…

Why was Centurion- Dressing Change Kits Dyndc1182b Picc 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: DYNDC1182B PICC INSERTION TRAY 2019020590 DYNDC1251D CENTRAL LINE TRAY 2019032590 DYNDC1251D CENTRAL LINE TRAY 2019020590 DYNDC1586C CENTRAL LINE DRESSING NGE TRAY 2019011590 DYNDC1597A CVC DRESSING CHANGE TRAY 2019032990 DYNDC1796C TRAY, CENTRAL LINE 2019031490 DYNDC1796C TRAY, CENTRAL LINE 2019012890 DYNDC1800 TRAY,PORT-A-CATH ACCESS 2018120490 DYNDC1855A CVC DRESSING CHANGE KIT 2018120490 DYNDC1870A SMALL DRESSING KIT 2019022590 DYNDC1945B PORT ACCESS KIT 2019012590 DYNDC1980B CVC DRESSING CHANGE KIT 2019041190 DYNDC1980B CVC DRESSING CHANGE KIT 2018121890 DYNDC1993 PORT ACCESS TRAY 2019031880 DYNDC1993 PORT ACCESS TRAY 2019030580 DYNDC1993 PORT ACCESS TRAY 2019030480 DYNDC1993 PORT ACCESS TRAY 2019012880 DYNDC1996B CENTRAL LINE DRESSING CHANGE 2018120590 DYNDC2004A IVAD KIT 2019013090 DYNDC2063D CENTRAL LINE DRESSING KIT 2019020590 DYNDC2063D CENTRAL LINE DRESSING KIT 2018092890 DYNDC2078 VAD DRESSING CHANGE TRAY 2019050680 DYNDC2078 VAD DRESSING CHANGE TRAY 2019030480 DYNDC2078 VAD DRESSING CHANGE TRAY 2019022580 DYNDC2078 VAD DRESSING CHANGE TRAY 2019011480 DYNDC2122B NEONATAL DRESSING CHANGE TRAY 2019060390 DYNDC2208C PEDIATRIC CENTRAL LINE SMALL 2018092590 DYNDC2215 DRESSING CHANGE W/CHG 2019010490 DYNDC2253 CENTRAL LINE DRESSING CHANGE 2018112690 DYNDC2278 CENTRAL LINE DRESSING CHANGE 2019022890 DYNDC2279 A LINE DRESSING CHANGE 2019050890 DYNDC2325A CVC DRESSING CHANGE 2018122190 DYNDC2338A PORT ACCESS KIT 2019031880 DYNDC2338A PORT ACCESS KIT 2019030480 DYNDC2396 CENTRAL LINE CAP CHANGE KIT 2018110690 DYNDC2451 PORT ACCESS KIT W/SALINE 2018122890 DYNDC2464B PORT DRESSING CHANGE KIT 2019032090 DYNDC2521 DRESSING CHANGE KIT SM LF 1921 2019022090 DYNDC2523 IMPLANTED PORT ACCESS KIT 2018121790 DYNDC2523 IMPLANTED PORT ACCESS KIT 2018100590 DYNDC2597A PHC IMPLANTED PORT TRAY 2019030190 DYNDC2597A PHC IMPLANTED PORT TRAY 2018122690 DYNDC2625 CNTRL LINE DRSG CHG/PORT KIT 2019032090 DYNDC2639 CENTRAL LINE CANCER CENTER 2019012490 DYNDC2645 LVAD KIT 2019011690 DYNDC2651A CENTRAL LINE/PICC DRSG CHG KIT LARGE 2019012190 DYNDC2691 Angio Port Kit w/High Grade Instruments 2018090590

Product
Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C CENTRAL LINE…
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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