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
FDA Recall Z-1053-2020 · Posted None
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Recalling FirmCenturion Medical Products Corporation
Recall StatusTerminated
Product CodeLRP
Date Initiated2019-12-11
Date Terminated2020-09-04
Reason for Recall
Incomplete seals on the sterile package may compromise the sterility
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Foreign: GHANA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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