Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1091-2020Class II

Centurion- ENT SNUF3 SNUFFER KIT Y

Centurion Medical Products, LP / initiated 2019-12-11 / Terminated / root cause: packaging

Centurion Medical Products Corporation began a recall of Centurion- ENT SNUF3 SNUFFER KIT Y on . FDA classified it as Class II and gives the reason as "Incomplete seals on the sterile package may compromise the sterility". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1091-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Centurion Medical Products, LP
Product
Centurion- ENT SNUF3 SNUFFER KIT Y
Product code
OGR Ear, Nose, And Throat Surgical Tray
Reason for recall
Incomplete seals on the sterile package may compromise the sterility
Root cause tag
packaging
FDA root cause
Packaging process control
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.
Quantity in commerce
146 units
Distribution
Nationwide Foreign: GHANA
Product codes and lots
Product/Description/Lot Numbers:  SNUF3 SNUFFER KIT Y 2019011490

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1091-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1042-2020Class IITerminatedVoluntary: Firm initiated
Z-1043-2020Class IITerminatedVoluntary: Firm initiated
Z-1044-2020Class IITerminatedVoluntary: Firm initiated
Z-1045-2020Class IITerminatedVoluntary: Firm initiated
Z-1046-2020Class IITerminatedVoluntary: Firm initiated
Z-1047-2020Class IITerminatedVoluntary: Firm initiated
Z-1048-2020Class IITerminatedVoluntary: Firm initiated
Z-1049-2020Class IITerminatedVoluntary: Firm initiated
Z-1050-2020Class IITerminatedVoluntary: Firm initiated
Z-1051-2020Class IITerminatedVoluntary: Firm initiated
Z-1052-2020Class IITerminatedVoluntary: Firm initiated
Z-1053-2020Class IITerminatedVoluntary: Firm initiated
Z-1054-2020Class IITerminatedVoluntary: Firm initiated
Z-1055-2020Class IITerminatedVoluntary: Firm initiated
Z-1056-2020Class IITerminatedVoluntary: Firm initiated
Z-1057-2020Class IITerminatedVoluntary: Firm initiated
Z-1058-2020Class IITerminatedVoluntary: Firm initiated
Z-1059-2020Class IITerminatedVoluntary: Firm initiated
Z-1060-2020Class IITerminatedVoluntary: Firm initiated
Z-1061-2020Class IITerminatedVoluntary: Firm initiated
Z-1062-2020Class IITerminatedVoluntary: Firm initiated
Z-1063-2020Class IITerminatedVoluntary: Firm initiated
Z-1064-2020Class IITerminatedVoluntary: Firm initiated
Z-1065-2020Class IITerminatedVoluntary: Firm initiated
Z-1066-2020Class IITerminatedVoluntary: Firm initiated
Z-1067-2020Class IITerminatedVoluntary: Firm initiated
Z-1068-2020Class IITerminatedVoluntary: Firm initiated
Z-1069-2020Class IITerminatedVoluntary: Firm initiated
Z-1070-2020Class IITerminatedVoluntary: Firm initiated
Z-1071-2020Class IITerminatedVoluntary: Firm initiated
Z-1072-2020Class IITerminatedVoluntary: Firm initiated
Z-1073-2020Class IITerminatedVoluntary: Firm initiated
Z-1074-2020Class IITerminatedVoluntary: Firm initiated
Z-1075-2020Class IITerminatedVoluntary: Firm initiated
Z-1076-2020Class IITerminatedVoluntary: Firm initiated
Z-1077-2020Class IITerminatedVoluntary: Firm initiated
Z-1078-2020Class IITerminatedVoluntary: Firm initiated
Z-1079-2020Class IITerminatedVoluntary: Firm initiated
Z-1080-2020Class IITerminatedVoluntary: Firm initiated
Z-1081-2020Class IITerminatedVoluntary: Firm initiated
Z-1082-2020Class IITerminatedVoluntary: Firm initiated
Z-1083-2020Class IITerminatedVoluntary: Firm initiated
Z-1084-2020Class IITerminatedVoluntary: Firm initiated
Z-1085-2020Class IITerminatedVoluntary: Firm initiated
Z-1086-2020Class IITerminatedVoluntary: Firm initiated
Z-1087-2020Class IITerminatedVoluntary: Firm initiated
Z-1088-2020Class IITerminatedVoluntary: Firm initiated
Z-1089-2020Class IITerminatedVoluntary: Firm initiated
Z-1090-2020Class IITerminatedVoluntary: Firm initiated
Z-1091-2020Class IITerminatedVoluntary: Firm initiated
Z-1092-2020Class IITerminatedVoluntary: Firm initiated
Z-1093-2020Class IITerminatedVoluntary: Firm initiated
Z-1094-2020Class IITerminatedVoluntary: Firm initiated
Z-1095-2020Class IITerminatedVoluntary: Firm initiated