Centurion- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1152A LA...
FDA Device Recall #Z-1053-2020 — Class II — December 11, 2019
Recall Summary
| Recall Number | Z-1053-2020 |
| 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- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1223A LACERATION TRAY DYNDL1295B KIT,PAIN DYNDL1436A LACERATION TRAY DYNDL1436A LACERATION TRAY DYNDL1600B RCHSD CVP TRAY DYNDL1606A VAGINAL DELIVERY TRAY DYNDL1617A PICC INSERTION KIT-LATEX FREE DYNDL1617A PICC INSERTION KIT-LATEX FREE DYNDL1630A LACERATION TRAY DYNDL1675 ARTHROGRAM TRAY DYNDL1721 LACERATION TRAY DYNDL1721 LACERATION TRAY DYNDL1741A LACERATION TRAY DYNDL1744 LACERATION KIT DYNDL1755 LACERATION TRAY DYNDL1764A LACERATION TRAY DYNDL1772 LACERATION TRAY DYNDL1772 LACERATION TRAY DYNDL1786 SUTURING SET DYNDL1790 LACERATION TRAY DYNDL1796 LACERATION TRAY DYNDL1812 PEDI LACERATION TRAY DYNDL1840 SUTURE SET PACK DYNDL1847 ER SUTURE TRAY DYNDL1864A LACERATION TRAY DYNDL1897 LACERATION TRAY DYNDL1897 LACERATION TRAY DYNDL1920 LACERATION TRAY
Reason for Recall
Incomplete seals on the sterile package may compromise the sterility
Distribution Pattern
Nationwide Foreign: GHANA
Lot / Code Information
Lot Numbers: DYNDL1073 LACERATION TRAY 2019011590 DYNDL1152A LACERATION TRAY 2018122790 DYNDL1152A LACERATION TRAY 2018092090 DYNDL1223A LACERATION TRAY 2018112190 DYNDL1295B KIT,PAIN 2018112690 DYNDL1436A LACERATION TRAY 2019010490 DYNDL1436A LACERATION TRAY 2018122190 DYNDL1600B RCHSD CVP TRAY 2019030890 DYNDL1606A VAGINAL DELIVERY TRAY 2018112190 DYNDL1617A PICC INSERTION KIT-LATEX FREE 2019032190 DYNDL1617A PICC INSERTION KIT-LATEX FREE 2018120390 DYNDL1630A LACERATION TRAY 2019011090 DYNDL1675 ARTHROGRAM TRAY 2019021290 DYNDL1721 LACERATION TRAY 2019032590 DYNDL1721 LACERATION TRAY 2018100590 DYNDL1741A LACERATION TRAY 2018111390 DYNDL1744 LACERATION KIT 2018121790 DYNDL1755 LACERATION TRAY 2018121890 DYNDL1764A LACERATION TRAY 2018112190 DYNDL1772 LACERATION TRAY 2019051690 DYNDL1772 LACERATION TRAY 2018122190 DYNDL1786 SUTURING SET 2019022790 DYNDL1790 LACERATION TRAY 2019012590 DYNDL1796 LACERATION TRAY 2018101590 DYNDL1812 PEDI LACERATION TRAY 2019061090 DYNDL1840 SUTURE SET PACK 2019031490 DYNDL1847 ER SUTURE TRAY 2019051390 DYNDL1864A LACERATION TRAY 2018112790 DYNDL1897 LACERATION TRAY 2018121090 DYNDL1897 LACERATION TRAY 2018111990 DYNDL1920 LACERATION TRAY 2018101290
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.