Recall Z-1054-2020

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-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIVERY INSTRUMENT TRAY MNS10620 PACEMAKER TRAY MNS10820 ENT/EPISTAXIS KIT MNS10920 PODIATRY NAIL PACK MNS10985 CERCLAGE REMOVAL KIT MNS11020 VAGINAL DELIVERY TRAY MNS11040 OB DELIVERY PROCEDURE PACK MNS11040 OB DELIVERY PROCEDURE PACK MNS11180 CUTDOWN TRAY MNS11380 CYSTO PROCEDURE KIT MNS11415 BIRTHING SET MNS11430 MYELOGRAM TRAY MNS11485 DERM ROOM TRAY MNS11490 VASECTOMY TRAY MNS11490 VASECTOMY TRAY MNS11605 STERILE FLUORO SSP TRAY MNS11720 OCULOPLASTICS INSTRUMENT SET MNS11780 MOHS INSTRUMENT PACK MNS11885 OB BASIC DELIVERY INSTRUMENT TRAY MNS11980 DERMATOLOGY TRAY MNS12045 LINE REPAIR KIT MNS12090 TOENAIL REMOVAL PACK MNS12140 HAND TRAY MNS12175 PACEMAKER TRAY MNS1320 E.N.T. TRAY MNS1445 VASECTOMY MNS1485 NOSEBLEED TRAY MNS1500 JOINT ASPIRATION KIT MNS1500 JOINT ASPIRATION KIT MNS1545 LATEX FREE NASAL HEMORRHAGE SET MNS1555 EPISTAXIS TRAY MNS1900 NOSEBLEED TRAY MNS1990 NASAL KIT MNS2105 EPISTAXIS TRAY MNS2170 NASAL PACKING TRAY MNS2225B MYELOGRAM TRAY MNS2225B MYELOGRAM TRAY MNS2845 U/S, BASIC BIOPSY TRAY MNS2975 ENT EPISTAXIS TRAY MNS3345A PEDIATRIC CUTDOWN TRAY MNS3450 IUD TRAY MNS3490 CHEMO KIT MNS3925 OB INSTRUMENT TRAY MNS4090A MINOR CUTDOWN TRAY MNS4110 THORACOTOMY TRAY MNS4120 NOSEBLEED TRAY MNS4215 OR VAGINAL DELIVERY TRAY MNS4360 BREAST BIOPSY KIT MNS4405 BIOPSY DERMATOLOGY KIT MNS4545 NASAL TRAY MNS4855 WOUND EXPLORATION/DPL TRAY MNS5170 NEONATAL PROCEDURE TRAY MNS5225 RENAL BIOPSY TRAY MNS5272 OB DELIVERY INSTRUMENT TRAY MNS5410 VAG DELIVERY INSTRUMENTS MNS5410 VAG DELIVERY INSTRUMENTS MNS5425 VAGINAL DELIVERY TRAY MNS5511 ARTHROGRAM TRAY MNS5575 OB DELIVERY TRAY MNS5750A VAGINAL DELIVERY SET MNS6025 GU MEATOTOMY MNS6025 GU MEATOTOMY MNS6260 BIOPSY TRAY MNS6285 MINOR PLASTIC SET MNS6395 VAGINAL DELIVERY KIT MNS6405 MULTI-PURPOSE RADIOLOGY TRAY MNS6820 RADIOLOGIST SPINAL TRAY MNS6880 BIOPSY TRAY MNS6985 PERCUTANEOUS CATHETER PLACEMENT TRAY MNS7155 TONGUE TIE KIT MNS7285 BIOPSY KIT- SHAVE MNS7285 BIOPSY KIT- SHAVE MNS7285 BIOPSY KIT- SHAVE MNS7295 BIOPSY KIT - SHAVE/PUNCH COMBO MNS7325 CATHETER REMOVAL TRAY MNS7415 NASAL HEMORRHAGE TRAY MNS7415 NASAL HEMORRHAGE TRAY MNS7575 MINOR TISSUE TRAY MNS7605 BREAST BIOPSY KIT MNS7815 DERMAL PACK MNS7900 C.T. BIOPSY TRAY MNS8010 EPISTAXIS TRAY MNS8445 SPINAL TRAY MNS8445 SPINAL TRAY MNS8475 ED TRACHEOTOMY TRAY MNS8645 BIOPSY KIT MNS8645 BIOPSY KIT MNS8915 BLOOD CULTURE COLLECTION KIT ; CVAD MNS9005 CENTRAL LINE REMOVAL TRAY MNS9106 ULTRASOUND BIOPSY TRAY MNS9106 ULTRASOUND BIOPSY TRAY MNS9170 CUTDOWN TRAY MNS9245 PACEMAKER TRAY MNS9335 IUD TRAY MNS9455 VAGINAL DELIVERY TRAY W/INSTRUMENTS MNS9480 VAGINAL DELIVERY TRAY MNS9480 VAGINAL DELIVERY TRAY MNS9625 TRACHEOSTOMY KIT MNS965 AMNIOCENTESIS TRAY MNS9710 IUD TRAY MNS9765 PORT INSERTION TRAY MNS9780 ARTHROGRAM TRAY MNS9820 OB PACK MNS9835 VAG DELIVERY TRAY MNS9835 VAG DELIVERY TRAY MNS9855 PACEMAKER INSTRUMENT TRAY MNS9870 DR. NELSON MOHS PACK MNS9870 DR. NELSON MOHS PACK MNS9935 CATH LAB INSTRUMENT KIT

Codes / lots: Lot Numbers: MNS10255 DELIVERY TRAY 2019012990 MNS10255 DELIVERY TRAY 2018100190 MNS10310 MEATOTOMY TRAY 2019031190 MNS10310 MEATOTOMY TRAY 2018103090 MNS10525 DELIVERY INSTRUMENT TRAY 2018100890 MNS10620 PACEMAKER TRAY 2019042990 MNS10820 ENT/EPISTAXIS KIT 2019011490 MNS10920 PODIATRY NAIL PACK 2018100890 MNS10985 CERCLAGE REMOVAL KIT 2018101290 MNS11020 VAGINAL DELIVERY TRAY 2019012390 MNS11040 OB DELIVERY PROCEDURE PACK 2018111490 MNS11040 OB DELIVERY PROCEDURE PACK 2018110890 MNS11180 CUTDOWN TRAY 2019050990 MNS11380 CYSTO PROCEDURE KIT 2018102290 MNS11415 BIRTHING SET 2018121490 MNS11430 MYELOGRAM TRAY 2019051590 MNS11485 DERM ROOM TRAY 2019053190 MNS11490 VASECTOMY TRAY 2019041190 MNS11490 VASECTOMY TRAY 2019012890 MNS11605 STERILE FLUORO SSP TRAY 2018111590 MNS11720 OCULOPLASTICS INSTRUMENT SET 2019060590 MNS11780 MOHS INSTRUMENT PACK 2019010490 MNS11885 OB BASIC DELIVERY INSTRUMENT TRAY 2019032090 MNS11980 DERMATOLOGY TRAY 2019031190 MNS12045 LINE REPAIR KIT 2019051590 MNS12090 TOENAIL REMOVAL PACK 2019052890 MNS12140 HAND TRAY 2019050990 MNS12175 PACEMAKER TRAY 2019060790 MNS1320 E.N.T. TRAY 2019020890 MNS1445 VASECTOMY 2019050690 MNS1485 NOSEBLEED TRAY 2019032090…

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-1054-2020
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-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-1057-2020 Class IICenturion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING…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