Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PR...
FDA Device Recall #Z-1047-2020 — Class II — December 11, 2019
Recall Summary
| Recall Number | Z-1047-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 11, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Centurion Medical Products Corporation |
| Location | Williamston, MI |
| Product Type | Devices |
| Quantity | N/A |
Product Description
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
Reason for Recall
Incomplete seals on the sterile package may compromise the sterility
Distribution Pattern
Nationwide Foreign: GHANA
Lot / 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
Other Recalls from Centurion Medical Products Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1070-2020 | Class II | Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY | Dec 11, 2019 |
| Z-1091-2020 | Class II | Centurion- ENT SNUF3 SNUFFER KIT Y | Dec 11, 2019 |
| Z-1063-2020 | Class II | Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENA... | Dec 11, 2019 |
| Z-1090-2020 | Class II | Centurion- Skin Prep Kits SB1280 SKIN SCRUB KI... | Dec 11, 2019 |
| Z-1058-2020 | Class II | Centurion- Umbilical Trays UVT1045 UMBILICAL A... | Dec 11, 2019 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.