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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion Laceration Trays

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 Class 2 Device Recall Centurion Laceration Trayssee related information
Date Initiated by FirmDecember 11, 2019
Create DateFebruary 05, 2020
Recall Status1 Terminated 3 on September 04, 2020
Recall NumberZ-1053-2020
Recall Event ID 84530
Product Classification Tray, surgical - Product Code LRP
ProductCenturion- 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
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 
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
For Additional Information ContactSAME
517-546-5400
Manufacturer Reason
for Recall		Incomplete seals on the sterile package may compromise the sterility
FDA Determined
Cause 2		Packaging 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. 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.
DistributionNationwide Foreign: GHANA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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