Class 2 Device Recall CenturionSuture Trays

• Date Initiated by Firm: December 11, 2019
• Create Date: February 05, 2020
• Recall Status: Terminated on September 04, 2020
• Recall Number: Z-1057-2020
• Recall Event ID: 84530
• Product Classification: Tray, surgical - Product Code LRP
• Product: Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING TRAY SUT10770 DEBRIDEMENT/SUTURE SET SUT10795 PORT IMPLANT SET SUT11035 SUTURE TRAY SUT11065 LACERATION TRAY SUT1113A SUTURING SET SUT11145 SNAGFREE SUTURE SET W/SURGICAL INST. SUT11515 LACERATION TRAY SUT11540A LACERATION TRAY SUT11590 SUTURE SET SUT11775 LACERATION TRAY SUT11780 MINOR TRAY SUT1189B LACERATION TRAY SUT11900 SUTURE TRAY SUT11910 LACERATION TRAY SUT11965 SUTURE SET SUT11970 SUTURE TRAY SUT12025 LACERATION TRAY SUT12225 SUTURE TRAY REGULAR SUT12275 SUTURING SET SUT12335 LACERATION TRAY SUT12625 SNAGFREE LACERATION TRAY SUT12765 SNAGFREE LACERATION TRAY SUT12895 SUTURE SET SUT12895 SUTURE SET SUT12895 SUTURE SET SUT12970 PLASTIC TRAY SUT13315 LACERATION TRAY SUT13400 SNAG FREE PLASTICS TRAY W/OR INSTRUMENTS SUT13510 LACERATION TRAY SUT13535 PLASTICS SUTURE TRAY SUT13550 LACERATION TRAY SUT13555 SUTURE TRAY SUT13620 LACERATION TRAY SUT13620 LACERATION TRAY SUT13720 LACERATION TRAY SUT13785 PLASTIC SUTURE TRAY SUT13830 LACERATION TRAY SUT13975 LACERATION TRAY SUT14000 ER SUTURE TRAY SUT14125 SUTURE SET W/SNAGFREE NEEDLEHOLDER SUT14125 SUTURE SET W/SNAGFREE NEEDLEHOLDER SUT14305 LACERATION TRAY SUT14355 SNAG FREE SUTURE TRAY SUT14370 ER FACIAL TRAY SUT14435 LACERATION TRAY W/ SAFETY NEEDLE SUT14655 LACERATION TRAY SUT14705 LACERATION TRAY SUT14730 MINOR SUTURE SET/ I&D TRAY SUT14730 MINOR SUTURE SET/ I&D TRAY SUT14800 NASAL SET SUT14805 TRACH SET SUT15085 LACERATION/INCISION & DRAINAGE TRAY SUT15140 LACERATION TRAY SUT15215 SNAG FREE LACERATION TRAY SUT15225 LACERATION TRAY SUT15255 LACERATION TRAY SUT15375 SUTURING SET SUT15390 SUTURE KIT SUT15430 ER SMALL SET SUT15525 SUTURE TRAY SUT15695 SUTURE SET SUT15735 SUTURE SET SUT15870 SUTURE SET SUT17015 SNAG FREE LACERATION TRAY SUT17015 SNAG FREE LACERATION TRAY SUT17080 RADIOLOGY LACERATION TRAY SUT17145 LACERATION TRAY SUT17155 LACERATION TRAY SUT17275 SUTURE SET SUT17500 SUTURE SET SUT17595 SNAGFREE LACERATION TRAY SUT17620 SUTURE TRAY SUT17620 SUTURE TRAY SUT17860 FINE PLASTICS TRAY SUT18150 LACERATION TRAY SUT18160 LACERATION TRAY SUT18160 LACERATION TRAY SUT18310 SNAGFREE LACERATION TRAY SUT18370 LACERATION TRAY SUT18425 TOENAIL EXCISION TRAY SUT18505 LACERATION TRAY SUT18510 SPECIALTY PLASTICS TRAY SUT18570 LACERATION TRAY SUT18655 FINE PLASTICS TRAY SUT18695 LACERATION TRAY SUT18765 LACERATION TRAY SUT18770 FINE PLASTIC SUTURE SET SUT18775 LACERATION TRAY SUT18810 SNAGFREE LACERATION TRAY SUT18890 LACERATION TRAY SUT18920 DR. DACEY SURGERY PACK SUT18920 DR. DACEY SURGERY PACK SUT18920 DR. DACEY SURGERY PACK SUT19050 LACERATION TRAY SUT19120 DERM SURGERY PACK SUT19170 TOENAIL KIT SUT19290A LACERATION TRAY SUT19340 LACERATION TRAY SUT19395 LACERATION TRAY SUT19450 SUTURE SET SUT19525 PLASTICS - PROCEDURE PACK SUT19615 PLASTICS SUTURE TRAY SUT19675 WOUND CLOSURE TRAY SUT19675 WOUND CLOSURE TRAY SUT20105 NAIL TRAY SUT20375 RECYCLABLE DERMATOLOGY MINOR SURGERY SET SUT20410 LACERATION TRAY SUT20410 LACERATION TRAY SUT20460 LACERATION TRAY SUT20500 LACERATION TRAY W/SNAGFREE NEEDLEHOLDER SUT20700 LACERATION TRAY SUT20745 LACERATION TRAY SUT20760 Wound Closure Tray SUT20780 CENTRAL LINE CATH KIT SUT20835 LACERATION TRAY SUT20965 LACERATION TRAY SUT20995 LACERATION TRAY SUT21010 DEBRIDEMENT TRAY SUT21015 PLASTIC SURGERY TRAY SUT21065 LACERATION TRAY SUT2220 LACERATION TRAY SUT2220 LACERATION TRAY SUT2750 SUTURING SET SUT2820 SUTURING SET SUT3100 FACIAL SUTURING SET SUT3780L LACERATION TRAY SUT5765 SUTURING SET SUT5765 SUTURING SET SUT6100 PLASTIC SUTURE GILLIES TRAY SUT6515 ST. JOSEPH ALL PURPOSE TRAY SUT6760 SUTURE TRAY SUT6960 CUSTOM LACERATION TRAY SUT6960 CUSTOM LACERATION TRAY SUT7980 LACERATION TRAY SUT8165 LACERATION TRAY SUT8295 LACERATION TRAY SUT8445 SATIN PLASTICS WOUND CLOSURE TRAY SUT8795 SUTURING SET SUT9005 SUTURING SET SUT9140
• Code Information: Lot Numbers: SUT10140 SUTURE TRAY 2019060690 SUT10290 LACERATION TRAY 2019011490 SUT10705 SUTURING TRAY 2019031590 SUT10770 DEBRIDEMENT/SUTURE SET 2019040190 SUT10795 PORT IMPLANT SET 2019022190 SUT11035 SUTURE TRAY 2018120590 SUT11065 LACERATION TRAY 2019020590 SUT1113A SUTURING SET 2019022090 SUT11145 SNAGFREE SUTURE SET W/SURGICAL INST. 2019042990 SUT11515 LACERATION TRAY 2019010490 SUT11540A LACERATION TRAY 2019040990 SUT11590 SUTURE SET 2019011790 SUT11775 LACERATION TRAY 2019021990 SUT11780 MINOR TRAY 2019010290 SUT1189B LACERATION TRAY 2019010490 SUT11900 SUTURE TRAY 2019021990 SUT11910 LACERATION TRAY 2018110590 SUT11965 SUTURE SET 2019011490 SUT11970 SUTURE TRAY 2019040490 SUT12025 LACERATION TRAY 2018100590 SUT12225 SUTURE TRAY REGULAR 2019011690 SUT12275 SUTURING SET 2019011790 SUT12335 LACERATION TRAY 2019012890 SUT12625 SNAGFREE LACERATION TRAY 2019042490 SUT12765 SNAGFREE LACERATION TRAY 2019011490 SUT12895 SUTURE SET 2018111690 SUT12895 SUTURE SET 2018103090 SUT12895 SUTURE SET 2018102290 SUT12970 PLASTIC TRAY 2019013090 SUT13315 LACERATION TRAY 2018092890 SUT13400 SNAG FREE PLASTICS TRAY W/OR INSTRUMENTS 2018100890 SUT13510 LACERATION TRAY 2018092090 SUT13535 PLASTICS SUTURE TRAY 2019041580 SUT13550 LACERATION TRAY 2019022790 SUT13555 SUTURE TRAY 2018120390 SUT13620 LACERATION TRAY 2019042290 SUT13620 LACERATION TRAY 2019031190 SUT13720 LACERATION TRAY 2019021190 SUT13785 PLASTIC SUTURE TRAY 2019053190 SUT13830 LACERATION TRAY 2019011590 SUT13975 LACERATION TRAY 2018122190 SUT14000 ER SUTURE TRAY 2018101790 SUT14125 SUTURE SET W/SNAGFREE NEEDLEHOLDER 2019032090 SUT14125 SUTURE SET W/SNAGFREE NEEDLEHOLDER 2019021990 SUT14305 LACERATION TRAY 2019010290 SUT14355 SNAG FREE SUTURE TRAY 2019042990 SUT14370 ER FACIAL TRAY 2019011790 SUT14435 LACERATION TRAY W/ SAFETY NEEDLE 2019013190 SUT14655 LACERATION TRAY 2019012890 SUT14705 LACERATION TRAY 2019011790 SUT14730 MINOR SUTURE SET/ I&D TRAY 2019020890 SUT14730 MINOR SUTURE SET/ I&D TRAY 2018100290 SUT14800 NASAL SET 2019013190 SUT14805 TRACH SET 2019042990 SUT15085 LACERATION/INCISION & DRAINAGE TRAY 2019012490 SUT15140 LACERATION TRAY 2019013190 SUT15215 SNAG FREE LACERATION TRAY 2018121090 SUT15225 LACERATION TRAY 2019052290 SUT15255 LACERATION TRAY 2018110290 SUT15375 SUTURING SET 2018100890 SUT15390 SUTURE KIT 2019013190 SUT15430 ER SMALL SET 2018101290 SUT15525 SUTURE TRAY 2018120690 SUT15695 SUTURE SET 2018120590 SUT15735 SUTURE SET 2018120690 SUT15870 SUTURE SET 2018121290 SUT17015 SNAG FREE LACERATION TRAY 2019042590 SUT17015 SNAG FREE LACERATION TRAY 2019012890 SUT17080 RADIOLOGY LACERATION TRAY 2019010490 SUT17145 LACERATION TRAY 2018102990 SUT17155 LACERATION TRAY 2018091690 SUT17275 SUTURE SET 2018102490 SUT17500 SUTURE SET 2019021190 SUT17595 SNAGFREE LACERATION TRAY 2018103190 SUT17620 SUTURE TRAY 2019042990 SUT17620 SUTURE TRAY 2018101290 SUT17860 FINE PLASTICS TRAY 2019042290 SUT18150 LACERATION TRAY 2019013190 SUT18160 LACERATION TRAY 2019010490 SUT18160 LACERATION TRAY 2018121790 SUT18310 SNAGFREE LACERATION TRAY 2019042490 SUT18370 LACERATION TRAY 2019041790 SUT18425 TOENAIL EXCISION TRAY 2018111590 SUT18505 LACERATION TRAY 2019061390 SUT18510 SPECIALTY PLASTICS TRAY 2019011590 SUT18570 LACERATION TRAY 2019011490 SUT18655 FINE PLASTICS TRAY 2018110990 SUT18695 LACERATION TRAY 2019012490 SUT18765 LACERATION TRAY 2019052990 SUT18770 FINE PLASTIC SUTURE SET 2019052190 SUT18775 LACERATION TRAY 2019020790 SUT18810 SNAGFREE LACERATION TRAY 2018113090 SUT18890 LACERATION TRAY 2018092090 SUT18920 DR. DACEY SURGERY PACK 2019032990 SUT18920 DR. DACEY SURGERY PACK 2019011490 SUT18920 DR. DACEY SURGERY PACK 2018121790 SUT19050 LACERATION TRAY 2018112690 SUT19120 DERM SURGERY PACK 2019041290 SUT19170 TOENAIL KIT 2018112190 SUT19290A LACERATION TRAY 2019042490 SUT19340 LACERATION TRAY 2018122190 SUT19395 LACERATION TRAY 2018121490 SUT19450 SUTURE SET 2019040590 SUT19525 PLASTICS - PROCEDURE PACK 2018111390 SUT19615 PLASTICS SUTURE TRAY 2018111490 SUT19675 WOUND CLOSURE TRAY 2019011490 SUT19675 WOUND CLOSURE TRAY 2018091690 SUT20105 NAIL TRAY 2019010490 SUT20375 RECYCLABLE DERMATOLOGY MINOR SURGERY SET 2018111990 SUT20410 LACERATION TRAY 2019042690 SUT20410 LACERATION TRAY 2019011490 SUT20460 LACERATION TRAY 2019011490 SUT20500 LACERATION TRAY W/SNAGFREE NEEDLEHOLDER 2019011590 SUT20700 LACERATION TRAY 2019011790 SUT20745 LACERATION TRAY 2019052090 SUT20760 Wound Closure Tray 2019040290 SUT20780 CENTRAL LINE CATH KIT 2019031990 SUT20835 LACERATION TRAY 2018101690 SUT20965 LACERATION TRAY 2019040190 SUT20995 LACERATION TRAY 2019032090 SUT21010 DEBRIDEMENT TRAY 2019052290 SUT21015 PLASTIC SURGERY TRAY 2018121890 SUT21065 LACERATION TRAY 2018121790 SUT2220 LACERATION TRAY 2019053190 SUT2220 LACERATION TRAY 2018120390 SUT2750 SUTURING SET 2018110790 SUT2820 SUTURING SET 2019022190 SUT3100 FACIAL SUTURING SET 2019020590 SUT3780L LACERATION TRAY 2019060690 SUT5765 SUTURING SET 2019042490 SUT5765 SUTURING SET 2019011490 SUT6100 PLASTIC SUTURE GILLIES TRAY 2019011890 SUT6515 ST. JOSEPH ALL PURPOSE TRAY 2019030480 SUT6760 SUTURE TRAY 2019020890 SUT6960 CUSTOM LACERATION TRAY 2019021290 SUT6960 CUSTOM LACERATION TRAY 2019013090 SUT7980 LACERATION TRAY 2018100490 SUT8165 LACERATION TRAY 2018092190 SUT8295 LACERATION TRAY 2018101790 SUT8445 SATIN PLASTICS WOUND CLOSURE TRAY 2019021390 SUT8795 SUTURING SET 2019040290 SUT9005 SUTURING SET 2019011590 SUT9140 SUTURE TRAY 2019011090 SUT9490 LACERATION TRAY 2019011590 SUT9596 LACERATION TRAY 2019012890 SUT9710A ER SUTURING TRAY 2019032290 SUT9710A ER SUTURING TRAY 2018092690 SUT9950A LACERATION TRAY 2018103190
• 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.