Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DY...
FDA Device Recall #Z-1049-2020 — Class II — December 11, 2019
Recall Summary
| Recall Number | Z-1049-2020 |
| 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 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
Reason for Recall
Incomplete seals on the sterile package may compromise the sterility
Distribution Pattern
Nationwide Foreign: GHANA
Lot / 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
Other Recalls from Centurion Medical Products Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1047-2020 | Class II | Centurion- Dressing Change Tray DT10290S CENTR... | 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.