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Class 2 Device Recall Centurion Circumsion Trays

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Class 2 Device Recall Centurion Circumsion Trays

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Date Initiated by Firm	December 11, 2019
Create Date	February 05, 2020
Recall Status¹	Terminated ³ on September 04, 2020
Recall Number	Z-1042-2020
Recall Event ID	84530
Product Classification	Circumsion Tray - Product Code OHG
Product	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
Code Information	Code Product Lot Number: CIT1270 CIRCUMCISION TRAY 2019012390 CIT2365 CIRCUMCISION TRAY 2018122890 CIT2465 CIRCUMCISION TRAY 2019061290 CIT2470 CIRC TRAY W/UNIVERSAL CLAMP 2019040590 CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL 2019040890 CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL 2018120390 CIT2510 CIRCUMCISION TRAY W/1.1 CM CLAMP 2019042990 CIT2530A CIRCUMCISION TRAY 2019021890 CIT2545 CIRCUMCISION TRAY 2019012890 CIT2630 CIRCUMCISION TRAY 2018100590 CIT2705 CIRCUMCISION TRAY 2019061290 CIT2730 CIRCUMCISION TRAY 2018102490 CIT3000 CIRCUMCISION TRAY 2019011490 CIT3010 CIRCUMCISION TRAY 2019050190 CIT3100 CIRCUMCISION TRAY 2019020890 CIT3145 UNIVERSAL CIRCUMCISION TRAY W/OUT CLAMP 2019040290 CIT3310 RECYCLABLE CIRCUMCISION TRAY 2019011490 CIT3315 CIRCUMCISION TRAY 2018122890 CIT3345 CIRCUMCISION TRAY 2018110190 CIT3465 L&D CIRCUMCISION SET 2019052890 CIT3690 CIRCUMCISION TRAY 2019032290 CIT3720 CIRCUMCISION TRAY 2019052890 CIT3725 CIRCUMCISION TRAY 2019050690 CIT3730 CIRCUMCISION TRAY 2019013190 CIT3800 CIRCUMCISION TRAY 2019040990 CIT3800 CIRCUMCISION TRAY 2018111590 CIT3835A UNIVERSAL CIRC TRAY W/SURGICAL INST 2018120590 CIT3865 CIRCUMCISION SET W/CLAMP AND 1.1 BELL 2018111590 CIT3890 CIRCUMCISION TRAY 2019030590 CIT4025 CIRCUMCISION TRAY 2018112690 CIT4080 CIRCUMCISION TRAY 2019020590 CIT4080 CIRCUMCISION TRAY 2018122190 CIT4080 CIRCUMCISION TRAY 2018100890 CIT4100 CIRCUMCISION TRAY - NO CLAMP 2019050690 CIT4100 CIRCUMCISION TRAY - NO CLAMP 2019010290 CIT4135 CIRCUMCISION TRAY 2018122790 CIT4140 CIRCUMCISION TRAY 2018120590 CIT4140 CIRCUMCISION TRAY 2018100890 CIT4180 CIRCUMCISION TRAY 2019060490 CIT4230 CIRCUMCISION TRAY 2019031590 CIT4260 CIRCUMCISION SET W/1.1 CLAMP 2018120590 CIT4335 CIRCUMCISION TRAY 2019040990 CIT4370 CIRCUMCISION TRAY 2018102990 CIT4400 CIRCUMCISION TRAY FOR CIRC CLAMP 2019040390 CIT4525 CIRCUMCISION TRAY 2019012290 CIT4775 CIRCUMCISION TRAY 2018112690 CIT4835 CIRCUMCISION TRAY WITH 1.3 CIRCLAMP 2018111490 CIT4840 CIRCUMCISION TRAY WITH 1.1 CIRCLAMP 2019011490 CIT4855 1.3 CIRCUMCISION TRAY CLAMP & BELL 2019030890 CIT5030 CIRCUMCISION TRAY 2019040190 CIT5135 UNIVERSAL CIRCUMCISION TRAY 2018100290 CIT5210 CIRCUMCISION TRAY 2019061080 CIT5290 UNIVERSAL CIRCUMCISION TRAY 2019031490 CIT5290 UNIVERSAL CIRCUMCISION TRAY 2019020790 CIT5295 CIRCUMCISION TRAY 2019010790 CIT5300 CIRCUMCISION TRAY 2019020190 CIT5340 CIRCUMCISION TRAY 2019040190 CIT5370 1.3 CIRCUMCISION TRAY 2018112090 CIT5375 CIRCUMCISION TRAY 2018100990 CIT5400 CIRCUMCISION TRAY 2018092090 CIT5460 UNIVERSAL CIRCUMCISION TRAY 2018110190 CIT5470 CIRCUMCISION TRAY W/1.1 BELL & CLAMP 2018102290 CIT5580 CIRCUMCISION KIT 2018121790 CIT5615 CIRCUMCISION TRAY 2018121990 CIT5615 CIRCUMCISION TRAY 2018091690 CIT5700 1.3 CIRCUMCISION KIT 2018112790 CIT5735 CIRCUMCISION TRAY 2019031490 CIT5745 CIRCUMCISION TRAY 2018121790 CIT5850 CIRCUMCISION TRAY 2018100990 CIT5955 CIRC TRAY WITH PVP AND SOFT STRAPS 2019061490 CIT6015 CIRCUMCISION TRAY 2018100890 CIT6050 CIRCUMCISION TRAY 2018101090 CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP 2018112790 CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP 2018111390 CIT6120 CIRCUMCISION TRAY 2019010490 CIT6200 CIRCUMCISION TRAY 2019012890 CIT6355 UNIVERSAL CIRCUMCISION TRAY 2019020890 CIT6365 CIRCUMCISION TRAY 2019042490 CIT6445 CIRCUMCISION TRAY 2018122090 CIT6545 CIRC TRAY 2019010490 CIT6560 CIRCUMCISION TRAY 2019021390 CIT6610A CIRCUMCISION TRAY NEWBORN NURSERY 2019031880 CIT6620 CIRCUMCISION TRAY 2019020790 CIT6635 CIRCUMCISION TRAY 2019043090 CIT6670 CIRCUMCISION TRAY 2018102990 CIT6685 CIRCUMCISION TRAY 2018102290 CIT6750 CIRCUMCISION TRAY 2018122090 CIT6860 CIRCUMCISION TRAY 2019061180 CIT6880 CIRCUMCISION TRAY 2019042590 CIT6920 NICU CIRCUMCISION TRAY W/OUT CLAMP 2019042590 CIT6935 CIRCUMCISION TRAY 2019052880
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 ²	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	1986
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.

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