BEUDAMED
    FDA Recall Terminated

    Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRCUMCISION TRAY CIT2470 CIRC TRAY W/UNIVERSAL CLAMP CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2510 CIRCUMCISION TRAY W/1.1 CM CLAMP CIT2530A CIRCUMCISION TRAY CIT2545 CIRCUMCISION TRAY CIT2630 CIRCUMCISION TRAY CIT2705 CIRCUMCISION TRAY CIT2730 CIRCUMCISION TRAY CIT3000 CIRCUMCISION TRAY CIT3010 CIRCUMCISION TRAY CIT3100 CIRCUMCISION TRAY CIT3145 UNIVERSAL CIRCUMCISION TRAY W/OUT CLAMP CIT3310 RECYCLABLE CIRCUMCISION TRAY CIT3315 CIRCUMCISION TRAY CIT3345 CIRCUMCISION TRAY CIT3465 L&D CIRCUMCISION SET CIT3690 CIRCUMCISION TRAY CIT3720 CIRCUMCISION TRAY CIT3725 CIRCUMCISION TRAY CIT3730 CIRCUMCISION TRAY CIT3800 CIRCUMCISION TRAY CIT3800 CIRCUMCISION TRAY CIT3835A UNIVERSAL CIRC TRAY W/SURGICAL INST CIT3865 CIRCUMCISION SET W/CLAMP AND 1.1 BELL CIT3890 CIRCUMCISION TRAY CIT4025 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4100 CIRCUMCISION TRAY - NO CLAMP CIT4100 CIRCUMCISION TRAY - NO CLAMP CIT4135 CIRCUMCISION TRAY CIT4140 CIRCUMCISION TRAY CIT4140 CIRCUMCISION TRAY CIT4180 CIRCUMCISION TRAY CIT4230 CIRCUMCISION TRAY CIT4260 CIRCUMCISION SET W/1.1 CLAMP CIT4335 CIRCUMCISION TRAY CIT4370 CIRCUMCISION TRAY CIT4400 CIRCUMCISION TRAY FOR CIRC CLAMP CIT4405 CIRCUMCISION TRAY FOR MOGEN CLAMP CIT4525 CIRCUMCISION TRAY CIT4775 CIRCUMCISION TRAY CIT4835 CIRCUMCISION TRAY WITH 1.3 CIRCLAMP CIT4840 CIRCUMCISION TRAY WITH 1.1 CIRCLAMP CIT4855 1.3 CIRCUMCISION TRAY CLAMP & BELL CIT5030 CIRCUMCISION TRAY CIT5135 UNIVERSAL CIRCUMCISION TRAY CIT5210 CIRCUMCISION TRAY CIT5290 UNIVERSAL CIRCUMCISION TRAY CIT5290 UNIVERSAL CIRCUMCISION TRAY CIT5295 CIRCUMCISION TRAY CIT5300 CIRCUMCISION TRAY CIT5340 CIRCUMCISION TRAY CIT5370 1.3 CIRCUMCISION TRAY CIT5375 CIRCUMCISION TRAY CIT5400 CIRCUMCISION TRAY CIT5460 UNIVERSAL CIRCUMCISION TRAY CIT5470 CIRCUMCISION TRAY W/1.1 BELL & CLAMP CIT5475 CIRCUMCISION TRAY CIT5495 CIRCUMCISION TRAY WITH UNIVERSAL CLAMP CIT5560 CIRC TRAY CIT5580 CIRCUMCISION KIT CIT5615 CIRCUMCISION TRAY CIT5615 CIRCUMCISION TRAY CIT5700 1.3 CIRCUMCISION KIT CIT5735 CIRCUMCISION TRAY CIT5745 CIRCUMCISION TRAY CIT5850 CIRCUMCISION TRAY CIT5955 CIRC TRAY WITH PVP AND SOFT STRAPS CIT6015 CIRCUMCISION TRAY CIT6050 CIRCUMCISION TRAY CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP CIT6120 CIRCUMCISION TRAY CIT6200 CIRCUMCISION TRAY CIT6355 UNIVERSAL CIRCUMCISION TRAY CIT6365 CIRCUMCISION TRAY CIT6445 CIRCUMCISION TRAY CIT6545 CIRC TRAY CIT6560 CIRCUMCISION TRAY CIT6610A CIRCUMCISION TRAY NEWBORN NURSERY CIT6620 CIRCUMCISION TRAY CIT6635 CIRCUMCISION TRAY CIT6670 CIRCUMCISION TRAY CIT6685 CIRCUMCISION TRAY CIT6750 CIRCUMCISION TRAY CIT6860 CIRCUMCISION TRAY CIT6880 CIRCUMCISION TRAY CIT6920 NICU CIRCUMCISION TRAY W/OUT CLAMP CIT6935 CIRCUMCISION TRAY

    Recall: Z-1042-2020 · Initiated December 11, 2019

    Recall

    Recall Number
    Z-1042-2020
    Event Number
    84530
    Firm
    Centurion Medical Products Corporation
    FEI Number
    3008403546
    Product Code
    OHG
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 11, 2019
    Terminated
    September 4, 2020
    Address
    100 Centurion Way, Williamston, MI, 48895-9086

    Description

    Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRCUMCISION TRAY CIT2470 CIRC TRAY W/UNIVERSAL CLAMP CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2510 CIRCUMCISION TRAY W/1.1 CM CLAMP CIT2530A CIRCUMCISION TRAY CIT2545 CIRCUMCISION TRAY CIT2630 CIRCUMCISION TRAY CIT2705 CIRCUMCISION TRAY CIT2730 CIRCUMCISION TRAY CIT3000 CIRCUMCISION TRAY CIT3010 CIRCUMCISION TRAY CIT3100 CIRCUMCISION TRAY CIT3145 UNIVERSAL CIRCUMCISION TRAY W/OUT CLAMP CIT3310 RECYCLABLE CIRCUMCISION TRAY CIT3315 CIRCUMCISION TRAY CIT3345 CIRCUMCISION TRAY CIT3465 L&D CIRCUMCISION SET CIT3690 CIRCUMCISION TRAY CIT3720 CIRCUMCISION TRAY CIT3725 CIRCUMCISION TRAY CIT3730 CIRCUMCISION TRAY CIT3800 CIRCUMCISION TRAY CIT3800 CIRCUMCISION TRAY CIT3835A UNIVERSAL CIRC TRAY W/SURGICAL INST CIT3865 CIRCUMCISION SET W/CLAMP AND 1.1 BELL CIT3890 CIRCUMCISION TRAY CIT4025 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4100 CIRCUMCISION TRAY - NO CLAMP CIT4100 CIRCUMCISION TRAY - NO CLAMP CIT4135 CIRCUMCISION TRAY CIT4140 CIRCUMCISION TRAY CIT4140 CIRCUMCISION TRAY CIT4180 CIRCUMCISION TRAY CIT4230 CIRCUMCISION TRAY CIT4260 CIRCUMCISION SET W/1.1 CLAMP CIT4335 CIRCUMCISION TRAY CIT4370 CIRCUMCISION TRAY CIT4400 CIRCUMCISION TRAY FOR CIRC CLAMP CIT4405 CIRCUMCISION TRAY FOR MOGEN CLAMP CIT4525 CIRCUMCISION TRAY CIT4775 CIRCUMCISION TRAY CIT4835 CIRCUMCISION TRAY WITH 1.3 CIRCLAMP CIT4840 CIRCUMCISION TRAY WITH 1.1 CIRCLAMP CIT4855 1.3 CIRCUMCISION TRAY CLAMP & BELL CIT5030 CIRCUMCISION TRAY CIT5135 UNIVERSAL CIRCUMCISION TRAY CIT5210 CIRCUMCISION TRAY CIT5290 UNIVERSAL CIRCUMCISION TRAY CIT5290 UNIVERSAL CIRCUMCISION TRAY CIT5295 CIRCUMCISION TRAY CIT5300 CIRCUMCISION TRAY CIT5340 CIRCUMCISION TRAY CIT5370 1.3 CIRCUMCISION TRAY CIT5375 CIRCUMCISION TRAY CIT5400 CIRCUMCISION TRAY CIT5460 UNIVERSAL CIRCUMCISION TRAY CIT5470 CIRCUMCISION TRAY W/1.1 BELL & CLAMP CIT5475 CIRCUMCISION TRAY CIT5495 CIRCUMCISION TRAY WITH UNIVERSAL CLAMP CIT5560 CIRC TRAY CIT5580 CIRCUMCISION KIT CIT5615 CIRCUMCISION TRAY CIT5615 CIRCUMCISION TRAY CIT5700 1.3 CIRCUMCISION KIT CIT5735 CIRCUMCISION TRAY CIT5745 CIRCUMCISION TRAY CIT5850 CIRCUMCISION TRAY CIT5955 CIRC TRAY WITH PVP AND SOFT STRAPS CIT6015 CIRCUMCISION TRAY CIT6050 CIRCUMCISION TRAY CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP CIT6120 CIRCUMCISION TRAY CIT6200 CIRCUMCISION TRAY CIT6355 UNIVERSAL CIRCUMCISION TRAY CIT6365 CIRCUMCISION TRAY CIT6445 CIRCUMCISION TRAY CIT6545 CIRC TRAY CIT6560 CIRCUMCISION TRAY CIT6610A CIRCUMCISION TRAY NEWBORN NURSERY CIT6620 CIRCUMCISION TRAY CIT6635 CIRCUMCISION TRAY CIT6670 CIRCUMCISION TRAY CIT6685 CIRCUMCISION TRAY CIT6750 CIRCUMCISION TRAY CIT6860 CIRCUMCISION TRAY CIT6880 CIRCUMCISION TRAY CIT6920 NICU CIRCUMCISION TRAY W/OUT CLAMP CIT6935 CIRCUMCISION TRAY

    Reason

    Incomplete seals on the sterile package may compromise the sterility

    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

    Quantity

    1986