| Date Initiated by Firm |
December 11, 2019 |
| Create Date |
February 05, 2020 |
| Recall Status1 |
Terminated 3 on September 04, 2020 |
| Recall Number |
Z-1047-2020 |
| Recall Event ID |
84530 |
| Product Classification |
Dressing change tray - Product Code OXQ
|
| Product |
Centurion- Dressing Change Tray
DT10290S CENTRAL LINE PREPARATION PACK
DT10290S CENTRAL LINE PREPARATION PACK
DT10415 PICC INSERTION TRAY
DT10495 PICC INSERTION TRAY
DT10525 CENTRAL LINE INSERTION DRAPE KIT
DT10675 CENTRAL LINE INSERTION PROCEDURE KIT
DT10755 DRESS UP KIT
DT10850 PORT DRESSING CHANGE TRAY
DT10850 PORT DRESSING CHANGE TRAY
DT11300 DIALYSIS ON/OFF KIT
DT11610 DRESSING CHANGE TRAY
DT11955 UNIVERSAL LINE FULL BODY DRAPE KIT - REG
DT12220 CVC DRESSING CHANGE TRAY
DT12270 DRESSING CHANGE TRAY
DT12270 DRESSING CHANGE TRAY
DT12415 NEONATAL PICC INSERTION TRAY
DT12415 NEONATAL PICC INSERTION TRAY
DT12485 PEDI CENT LINE TRAY W/SORB SHIELD
DT12540 CENTRAL LINE PACK
DT12555 UNIVERSAL CVC INS SUPP TRAY
DT12725 CENTRAL LINE DRESSING TRAY
DT12900 CL / PICC DRESSING CHANGE TRAY
DT13005A CVC DRESSING CHANGE TRAY
DT13055 PICC/CENTRAL LINE DRESSING CHANGE
DT13055 PICC/CENTRAL LINE DRESSING CHANGE
DT13055 PICC/CENTRAL LINE DRESSING CHANGE
DT13125 CENTRAL LINE TRAY
DT13525 DRESSING CHANGE TRAY
DT13560 PORT ACCESS TRAY
DT13560 PORT ACCESS TRAY
DT13560 PORT ACCESS TRAY
DT13635 DRESSING CHANGE TRAY
DT13725 ON/OFF KITS
DT13835 DRESSING CHANGE TRAY W/BIOPATCH
DT13885 DRESSING CHANGE TRAY
DT14065 CVC KIT
DT14100 CENTRAL LINE DSG CHG TRAY W/BIOPATCH
DT14135 PICC/CVC DRSG CHNG TRAY W/SORB SHIELD
DT14180 UNIVERSAL CATHETER INSERTION SET
DT14215 CVC LINE DRESSING CHANGE
DT14215 CVC LINE DRESSING CHANGE
DT14380 PICC MAINTENANCE PACK
DT14470 CVC DRSG CH W/BIOPATCH & SORB SHLD
DT14500 CENTRAL LINE DRESSING CHANGE TRAY
DT14500 CENTRAL LINE DRESSING CHANGE TRAY
DT14500 CENTRAL LINE DRESSING CHANGE TRAY
DT14650 MAXIMUM PROTECTION KIT
DT14865 PORT CATH FLUSH KIT
DT14965 PROCEDURE KIT
DT15160 ADULT PORT FLUSH KIT
DT15370 IN-PATIENT VAD KIT
DT15370 IN-PATIENT VAD KIT
DT15600 DRESSING CHANGE TRAY
DT15605A CVC DRESSING CHANGE TRAY
DT15655 CVC INSERTION TRAY
DT15775 NICU PICC LINE DRESSING CHANGE KIT
DT15780A PORT AND IO ACCESS DRESSING KIT
DT15970 MAXIMUM PROTECTION KIT
DT15970 MAXIMUM PROTECTION KIT
DT15975 CENTRAL LINE INSERTION KIT
DT15995 BOND CLINIC PORT DRESSING TRAY
DT16435 CENTRAL LINE DRESSING KIT
DT16480 PICC CENTRAL CVC CHANGE TRAY
DT16550 ICU ARTERIAL LINE TRAY
DT16550 ICU ARTERIAL LINE TRAY
DT17055 CENTRAL LINE ACCESSORY PACK
DT17120 VAD ACCESS KIT
DT17135 NEONATAL DRESSING CHANGE TRAY
DT17265 SUBC/PICC DRESS TRAY W/4MM BIOPATCH
DT17365 SINGLE PORT ACCESS TRAY
DT17380 IJ VAS-CATH DRESSING CHANGE TRAY
DT17410 ON/OFF KIT & DRESSING CHANGE TRAY
DT17420 ACCESS PORT KIT
DT17500 PICC DRESSING KIT
DT17675 DRIVELINE MANAGEMENT SYSTEM W/O BIOPATCH
DT17745 DRESSING CHANGE TRAY
DT17850 PORT DRESSING TRAY WITH BIOPATCH
DT17870 WEEKLY DRIVELINE MANAGEMENT SYSTEM
DT17965 PORT ACCESS TRAY
DT18030 PORT ACCESS TRAY
DT18375 DRIVELINE MANAGEMENT SYSTEM (W)
DT18395 PORT ACCESS TRAY
DT18415 PORT DRESSING CHANGE TRAY
DT18450 PORT ACCESS DRESSING CHANGE TRAY
DT18545 PORT DRESSING CHANGE TRAY
DT18600 DRIVELINE MANAGEMENT SYSTEM w/CHG
DT18600 DRIVELINE MANAGEMENT SYSTEM w/CHG
DT18655 DAILY LVAD DRESSING KIT
DT18675 LVAD MANAGEMENT SYSTEM-WEEKLY
DT18690 DRIVELINE MANAGEMENT SYSTEM
DT18690 DRIVELINE MANAGEMENT SYSTEM
DT18695A DRIVELINE MGMT. KIT WITH SILVER ALGINATE
DT18775 PORT ACCESS TRAY
DT19625 PORT ACCESS TRAY
DT19665 CENTRAL LINE DRESSING CHANGE KIT
DT19665 CENTRAL LINE DRESSING CHANGE KIT
DT19820 PEDIATRIC DRESSING CHANGE TRAY
DT19835A PEDIATRIC PORT ACCESS BUNDLE
DT19840 PORT ACCESS TRAY
DT19900 CENTRAL LINE DRESSING CHANGE OVAL SHIELD
DT20060 PORT ACCESS KIT
DT20100 PORT ACCESS TRAY W/SECUREVIEW
DT20160 PORT ACCESS KIT
DT20335 KAISER CENTRAL LINE MANAGEMENT SYSTEM
DT20335 KAISER CENTRAL LINE MANAGEMENT SYSTEM
DT20350A DIALYSIS OFF KIT
DT20370A CVC/PORT ACCESS TRAY
DT20385 CENTRAL LINE DRESSING KIT
DT20405 PICU MAX BARRIER KIT
DT20480 PICC AND PORT DRESSING KIT
DT20570 CENTRAL LINE CARE & MAINTENANCE BUNDLE
DT20640 PORT DRESSING CHANGE TRAY
DT20 |
| Code Information |
Lot Numbers: DT10290S CENTRAL LINE PREPARATION PACK 2019052490 DT10290S CENTRAL LINE PREPARATION PACK 2019020890 DT10415 PICC INSERTION TRAY 2018120390 DT10495 PICC INSERTION TRAY 2018121490 DT10525 CENTRAL LINE INSERTION DRAPE KIT 2018122690 DT10675 CENTRAL LINE INSERTION PROCEDURE KIT 2019020890 DT10755 DRESS UP KIT 2019040290 DT10850 PORT DRESSING CHANGE TRAY 2019022090 DT10850 PORT DRESSING CHANGE TRAY 2019013190 DT11300 DIALYSIS ON/OFF KIT 2019032190 DT11610 DRESSING CHANGE TRAY 2018100390 DT11955 UNIVERSAL LINE FULL BODY DRAPE KIT - REG 2019020590 DT12220 CVC DRESSING CHANGE TRAY 2019030790 DT12270 DRESSING CHANGE TRAY 2019061490 DT12270 DRESSING CHANGE TRAY 2019050990 DT12415 NEONATAL PICC INSERTION TRAY 2019050690 DT12415 NEONATAL PICC INSERTION TRAY 2019042490 DT12485 PEDI CENT LINE TRAY W/SORB SHIELD 2019011490 DT12540 CENTRAL LINE PACK 2019021190 DT12555 UNIVERSAL CVC INS SUPP TRAY 2019052890 DT12725 CENTRAL LINE DRESSING TRAY 2019011790 DT12900 CL / PICC DRESSING CHANGE TRAY 2019010490 DT13005A CVC DRESSING CHANGE TRAY 2019060590 DT13055 PICC/CENTRAL LINE DRESSING CHANGE 2019031290 DT13055 PICC/CENTRAL LINE DRESSING CHANGE 2019021290 DT13055 PICC/CENTRAL LINE DRESSING CHANGE 2018121090 DT13125 CENTRAL LINE TRAY 2019012890 DT13525 DRESSING CHANGE TRAY 2019032590 DT13560 PORT ACCESS TRAY 2019031490 DT13560 PORT ACCESS TRAY 2019011590 DT13560 PORT ACCESS TRAY 2018100590 DT13635 DRESSING CHANGE TRAY 2019040290 DT13725 ON/OFF KITS 2018100190 DT13835 DRESSING CHANGE TRAY W/BIOPATCH 2019022590 DT13885 DRESSING CHANGE TRAY 2019010290 DT14065 CVC KIT 2019031290 DT14100 CENTRAL LINE DSG CHG TRAY W/BIOPATCH 2019030890 DT14135 PICC/CVC DRSG CHNG TRAY W/SORB SHIELD 2018100890 DT14180 UNIVERSAL CATHETER INSERTION SET 2019012390 DT14215 CVC LINE DRESSING CHANGE 2019010490 DT14215 CVC LINE DRESSING CHANGE 2018121790 DT14380 PICC MAINTENANCE PACK 2019050680 DT14470 CVC DRSG CH W/BIOPATCH & SORB SHLD 2019021290 DT14500 CENTRAL LINE DRESSING CHANGE TRAY 2019013190 DT14500 CENTRAL LINE DRESSING CHANGE TRAY 2018121990 DT14500 CENTRAL LINE DRESSING CHANGE TRAY 2018121790 DT14650 MAXIMUM PROTECTION KIT 2018111990 DT14865 PORT CATH FLUSH KIT 2018120590 DT14965 PROCEDURE KIT 2019011590 DT15160 ADULT PORT FLUSH KIT 2018121790 DT15370 IN-PATIENT VAD KIT 2019052190 DT15370 IN-PATIENT VAD KIT 2018100890 DT15600 DRESSING CHANGE TRAY 2018101290 DT15605A CVC DRESSING CHANGE TRAY 2018101190 DT15655 CVC INSERTION TRAY 2019012390 DT15775 NICU PICC LINE DRESSING CHANGE KIT 2018102990 DT15780A PORT AND IO ACCESS DRESSING KIT 2018120690 DT15970 MAXIMUM PROTECTION KIT 2019052190 DT15970 MAXIMUM PROTECTION KIT 2019012390 DT15975 CENTRAL LINE INSERTION KIT 2019012290 DT15995 BOND CLINIC PORT DRESSING TRAY 2018110590 DT16435 CENTRAL LINE DRESSING KIT 2019031390 DT16480 PICC CENTRAL CVC CHANGE TRAY 2018122090 DT16550 ICU ARTERIAL LINE TRAY 2019011690 DT16550 ICU ARTERIAL LINE TRAY 2018100890 DT17055 CENTRAL LINE ACCESSORY PACK 2019021290 DT17120 VAD ACCESS KIT 2019042490 DT17135 NEONATAL DRESSING CHANGE TRAY 2018111490 DT17265 SUBC/PICC DRESS TRAY W/4MM BIOPATCH 2019010290 DT17365 SINGLE PORT ACCESS TRAY 2019042290 DT17380 IJ VAS-CATH DRESSING CHANGE TRAY 2018122190 DT17410 ON/OFF KIT & DRESSING CHANGE TRAY 2019060380 DT17420 ACCESS PORT KIT 2019050990 DT17500 PICC DRESSING KIT 2018100890 DT17675 DRIVELINE MANAGEMENT SYSTEM W/O BIOPATCH 2018110690 DT17745 DRESSING CHANGE TRAY 2018122190 DT17850 PORT DRESSING TRAY WITH BIOPATCH 2019042290 DT17870 WEEKLY DRIVELINE MANAGEMENT SYSTEM 2018100290 DT17965 PORT ACCESS TRAY 2019010290 DT18030 PORT ACCESS TRAY 2019051390 DT18375 DRIVELINE MANAGEMENT SYSTEM (W) 2018121390 DT18395 PORT ACCESS TRAY 2019010490 DT18415 PORT DRESSING CHANGE TRAY 2019013190 DT18450 PORT ACCESS DRESSING CHANGE TRAY 2018100890 DT18545 PORT DRESSING CHANGE TRAY 2018111390 DT18600 DRIVELINE MANAGEMENT SYSTEM w/CHG 2018122890 DT18600 DRIVELINE MANAGEMENT SYSTEM w/CHG 2018121490 DT18655 DAILY LVAD DRESSING KIT 2018121190 DT18675 LVAD MANAGEMENT SYSTEM-WEEKLY 2018112190 DT18690 DRIVELINE MANAGEMENT SYSTEM 2018121790 DT18690 DRIVELINE MANAGEMENT SYSTEM 2018103190 DT18695A DRIVELINE MGMT. KIT WITH SILVER ALGINATE 2018111590 DT18775 PORT ACCESS TRAY 2019011480 DT19625 PORT ACCESS TRAY 2019021290 DT19665 CENTRAL LINE DRESSING CHANGE KIT 2019060490 DT19665 CENTRAL LINE DRESSING CHANGE KIT 2019011590 DT19820 PEDIATRIC DRESSING CHANGE TRAY 2019032690 DT19835A PEDIATRIC PORT ACCESS BUNDLE 2019021990 DT19840 PORT ACCESS TRAY 2019022590 DT19900 CENTRAL LINE DRESSING CHANGE OVAL SHIELD 2018100590 DT20060 PORT ACCESS KIT 3000379589 DT20100 PORT ACCESS TRAY W/SECUREVIEW 2018121790 DT20160 PORT ACCESS KIT 2018121790 DT20335 KAISER CENTRAL LINE MANAGEMENT SYSTEM 2019020890 DT20335 KAISER CENTRAL LINE MANAGEMENT SYSTEM 2018111590 DT20350A DIALYSIS OFF KIT 2019021490 DT20370A CVC/PORT ACCESS TRAY 2019021390 DT20385 CENTRAL LINE DRESSING KIT 2019031290 DT20405 PICU MAX BARRIER KIT 2018101990 DT20480 PICC AND PORT DRESSING KIT 2018101590 DT20570 CENTRAL LINE CARE & MAINTENANCE BUNDLE 2019061780 DT20640 PORT DRESSING CHANGE TRAY 2019010290 DT20660 DIALYSIS DRESSING CHANGE BNDL W/SHIELD 2018101290 DT20685 CENTRAL LINE DRESSING CHANGE KIT 2019020790 DT20695 CVC KIT W/BIOPATCH 2019010290 DT20730 PICC/CENTRAL LINE KIT WITH CHG DRESSING 2019031390 DT20875 PORT ACCESS TRAY 2019020790 DT20875 PORT ACCESS TRAY 2018122890 DT20890B IMPLANTED PORT ACCESS BUNDLE 2018110190 DT20905 PORT ACCESS BUNDLE 2018120590 DT20940 DRESSING TRAY - OUTPATIENT PORT ACCESS 2019030690 DT21110 SHORT TERM PORT ACCESS KIT 2019011190 DT21115 DRESSING CHANGE TRAY - GOLD 2019040890 DT21115 DRESSING CHANGE TRAY - GOLD 2019012490 DT21315 CVC DRESSING CHANGE KIT 2019011190 DT21320 LARGE CANNULA DRESSING CHANGE TRAY 2018111490 DT21370 DIALYSIS DRESSING CHANGE KIT 2019012890 DT21375 HH PACK CENTRAL LINE DRESSING CHG 2018121890 DT21375 HH PACK CENTRAL LINE DRESSING CHG 2018112990 DT21400 CENTRAL LINE DRESSING CHANGE KIT 2019031490 DT21420 NICU DRESSING CHANGE KIT 2019011690 DT21460 DRESSING CHANGE TRAY W/TEGADERM CHG 2019022090 DT21460 DRESSING CHANGE TRAY W/TEGADERM CHG 2019011090 DT21465 DRESSING CHANGE TRAY WITHOUT DRESSING 2019021990 DT21535 PREP TRAY 2018102590 DT21580 PICC DRESSING CHANGE KIT 2018101190 DT21675 PORT ACCESS KIT 2019040890 DT21710 TUR ADD ON PACK 2019021490 DT21795 DIALYSIS DRESSING CHANGE BUNDLE 2019032290 DT21815 CENTRAL LINE DRESSING CHANGE KIT 2019010290 DT21870 VAD TRAY 2019013090 DT22220 PICC DRESSING CHANGE KIT 2019060490 DT22230 CVC DRESSING CHANGE TRAY 2019060590 DT2330 DR. MARGLE'S HAND KIT 2018112990 DT3125 LATEX FREE EPIDURAL TRAY 2019012190 DT4965 DRESSING CHANGE/INSERTION TRAY 2019022790 DT5045A DRESSING CHANGE TRAY 2019012190 DT5410 V.A.D. ACCESS TRAY 2019032790 DT6025 CENTRAL LINE DRESSING CHANGE TRAY 2019022590 DT6025 CENTRAL LINE DRESSING CHANGE TRAY 2018110590 DT6230 DRESSING CHANGE TRAY 2018120390 DT6300 DRESSING CHANGE KIT 2019031190 DT6755 VASCULAR ACCESS DEVICE DRESSING CHG TRAY 2018120490 DT7150 PORT ACCESS TRAY 2019050990 DT7480 ON/OFF TRAY 2018101290 DT7780 PORT ACCESS TRAY 2019022580 DT7785 SUBCLAVIAN TRAY 2019042590 DT8180 CENTRAL VENOUS ACCESS DRSG. CHG. TRAY LF 2018102990 DT8765 DRESSING CHANGE TRAY 2019042290 DT8960A PORT ACCESS KIT 2019010290 DT9120A PORT ACCESS KIT 2019053190 DT9650 DRESSING CHANGE TRAY 2018121290 DT9725 DRESSING CHANGE TRAY 2019031190 DT9725 DRESSING CHANGE TRAY 2018120390 |
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.
|
