Class 2 Device Recall CenturionPelvic

• Date Initiated by Firm: December 11, 2019
• Create Date: February 05, 2020
• Recall Status: Terminated on September 04, 2020
• Recall Number: Z-1055-2020
• Recall Event ID: 84530
• Product Classification: Pelvic exam kit - Product Code MLT
• Product: Centurion-Pelvic; PE120 LARGE/MEDIUM PELVIC TRAY; PE2200 PELVIC EXAM TRAY; PE2200 PELVIC EXAM TRAY; PE2400 PELVIC EXAM TRAY; PE2515 SMALL GYN EXAM TRAY; PE2515 SMALL GYN EXAM TRAY; PE2610 PELVIC EXAM TRAY; PE2700 ULTRASOUND TRAY; PE2700 ULTRASOUND TRAY; PE2820 VAG/VIRGIN VAG EXAM TRAY; PE2835 PELVIC EXAM TRAY; PE2835 PELVIC EXAM TRAY; PE2905 HSG TRAY; PE2955 7PELVIC EXAM TRAY; PE2965 DISPOSABLE PELVIC EXAM TRAY; PE2965 DISPOSABLE PELVIC EXAM TRAY; PE3125 PELVIC EXAM TRAY; PE3195 PELVIC EXAM TRAY; PE3285 PELVIC EXAM TRAY; PE3360 PELVIC EXAM TRAY W/LIGHT; PE3375 PELVIC EXAM TRAY; PE3400 MEDIUM GYN EXAM TRAY; PE3475 IUD TRAY; PE3585 MEDIUM/LARGE PELVIC EXAM TRAY; PE860 VAGINAL BLEEDER KIT
• Code Information: Lot Numbers: PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2610 PELVIC EXAM TRAY PE2700 ULTRASOUND TRAY PE2700 ULTRASOUND TRAY PE2820 VAG/VIRGIN VAG EXAM TRAY PE2835 PELVIC EXAM TRAY PE2835 PELVIC EXAM TRAY PE2905 HSG TRAY PE2955 7PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE3125 PELVIC EXAM TRAY PE3195 PELVIC EXAM TRAY PE3285 PELVIC EXAM TRAY PE3360 PELVIC EXAM TRAY W/LIGHT PE3375 PELVIC EXAM TRAY PE3400 MEDIUM GYN EXAM TRAY PE3475 IUD TRAY PE3585 MEDIUM/LARGE PELVIC EXAM TRAY PE860 VAGINAL BLEEDER KIT
• Recalling Firm/ Manufacturer: Centurion Medical Products Corporation; 100 Centurion Way; Williamston MI 48895-9086
• For Additional Information Contact: SAME; 517-546-5400
• Manufacturer Reason for Recall: Incomplete seals on the sterile package may compromise the sterility
• FDA Determined 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.
• Distribution: Nationwide Foreign: GHANA
• Total Product Life Cycle: TPLC 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.