Recall Z-1057-2020

Centurion Medical Products Corporation · initiated December 11, 2019

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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

Codes / lots: 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…

Reason for recall

Incomplete seals on the sterile package may compromise the sterility

FDA-determined cause: Packaging process control

Action taken

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.

Details

Recall number
Z-1057-2020
Initiated
December 11, 2019
Terminated
September 4, 2020
Product code
LRP – Tray, Surgical
Distribution
Nationwide Foreign: GHANA
Recalling firm
Centurion Medical Products Corporation, Williamston, MI

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1042-2020 Class IICenturion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1043-2020 Class IICenturion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1044-2020 Class IICenturion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1045-2020 Class IICenturion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1046-2020 Class IICenturion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y 2019011690Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1047-2020 Class IICenturion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1048-2020 Class IICenturion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1049-2020 Class IICenturion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1050-2020 Class IICenturion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1051-2020 Class IICenturion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1052-2020 Class IICenturion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1053-2020 Class IICenturion- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION TRAY…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1054-2020 Class IICenturion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1055-2020 Class IICenturion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1056-2020 Class IICenturion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1058-2020 Class IICenturion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1059-2020 Class IICenturion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1060-2020 Class IICenturion-BLOOD CULTURE COLLECTION KIT BP115 BLOOD CULTURE COLLECTION KITIncomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1061-2020 Class IICenturion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1062-2020 Class IICenturion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSYIncomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1063-2020 Class IICenturion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1064-2020 Class IICenturion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1065-2020 Class IICenturion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1066-2020 Class IICenturion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1067-2020 Class IICenturion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1068-2020 Class IICenturion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1069-2020 Class IICenturion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE…Incomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1070-2020 Class IICenturion- Biopsy Tray TRIBT170 BIOPSY TRAYIncomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1071-2020 Class IICenturion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEMIncomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated
Z-1072-2020 Class IICenturion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHTIncomplete seals on the sterile package may compromise the sterility 12/11/2019Terminated