| Date Initiated by Firm |
December 11, 2019 |
| Create Date |
February 05, 2020 |
| Recall Status1 |
Terminated 3 on September 04, 2020 |
| Recall Number |
Z-1049-2020 |
| Recall Event ID |
84530 |
| Product Classification |
Dressing change tray - Product Code OXQ
|
| Product |
Centurion- Dressing Change Kits
DYNDC1182B PICC INSERTION TRAY
DYNDC1251D CENTRAL LINE TRAY
DYNDC1251D CENTRAL LINE TRAY
DYNDC1586C CENTRAL LINE DRESSING NGE TRAY
DYNDC1597A CVC DRESSING CHANGE TRAY
DYNDC1796C TRAY, CENTRAL LINE
DYNDC1796C TRAY, CENTRAL LINE
DYNDC1800 TRAY,PORT-A-CATH ACCESS
DYNDC1855A CVC DRESSING CHANGE KIT
DYNDC1870A SMALL DRESSING KIT
DYNDC1945B PORT ACCESS KIT
DYNDC1980B CVC DRESSING CHANGE KIT
DYNDC1980B CVC DRESSING CHANGE KIT
DYNDC1993 PORT ACCESS TRAY
DYNDC1993 PORT ACCESS TRAY
DYNDC1993 PORT ACCESS TRAY
DYNDC1993 PORT ACCESS TRAY
DYNDC1996B CENTRAL LINE DRESSING CHANGE
DYNDC2004A IVAD KIT
DYNDC2063D CENTRAL LINE DRESSING KIT
DYNDC2063D CENTRAL LINE DRESSING KIT
DYNDC2078 VAD DRESSING CHANGE TRAY
DYNDC2078 VAD DRESSING CHANGE TRAY
DYNDC2078 VAD DRESSING CHANGE TRAY
DYNDC2078 VAD DRESSING CHANGE TRAY
DYNDC2122B NEONATAL DRESSING CHANGE TRAY
DYNDC2208C PEDIATRIC CENTRAL LINE SMALL
DYNDC2215 DRESSING CHANGE W/CHG
DYNDC2253 CENTRAL LINE DRESSING CHANGE
DYNDC2278 CENTRAL LINE DRESSING CHANGE
DYNDC2279 A LINE DRESSING CHANGE
DYNDC2325A CVC DRESSING CHANGE
DYNDC2338A PORT ACCESS KIT
DYNDC2338A PORT ACCESS KIT
DYNDC2396 CENTRAL LINE CAP CHANGE KIT
DYNDC2451 PORT ACCESS KIT W/SALINE
DYNDC2464B PORT DRESSING CHANGE KIT
DYNDC2521 DRESSING CHANGE KIT SM LF 1921
DYNDC2523 IMPLANTED PORT ACCESS KIT
DYNDC2523 IMPLANTED PORT ACCESS KIT
DYNDC2597A PHC IMPLANTED PORT TRAY
DYNDC2597A PHC IMPLANTED PORT TRAY
DYNDC2625 CNTRL LINE DRSG CHG/PORT KIT
DYNDC2639 CENTRAL LINE CANCER CENTER
DYNDC2645 LVAD KIT
DYNDC2651A CENTRAL LINE/PICC DRSG CHG KIT LARGE
DYNDC2691 Angio Port Kit w/High Grade Instruments
|
| Code Information |
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 |
Recalling Firm/
Manufacturer |
Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
|
| For Additional Information Contact |
SAME
517-546-5400
|
Manufacturer Reason
for Recall |
Incomplete seals on the sterile package may compromise the sterility
|
FDA Determined
Cause 2 |
Packaging process control |
| Action |
Centurion issued a notification emailed to Medline Industries,
Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall
communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please complete the enclosed accountability record, whether or not you have product, and fax or email at
your earliest convenience to the attention of Lisa Carpenter, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122. |
| Distribution |
Nationwide
Foreign: GHANA |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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