ClearanceBrief
Recall Z-1059-2020 ยท LRP Tray, Surgical

Centurion Medical Products Corporation

Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL VESSEL CATH. INSERTION

DateDec 11, 2019
StatusTerminated
ReasonIncomplete seals on the sterile package may compromise the sterility
Root causePackaging process control
ActionCenturion 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. Pleas
DistributionNationwide Foreign: GHANA
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.