Class 2 Device Recall CenturionSurgical Tray

• Date Initiated by Firm: December 11, 2019
• Create Date: February 05, 2020
• Recall Status: Terminated on September 04, 2020
• Recall Number: Z-1054-2020
• Recall Event ID: 84530
• Product Classification: Tray, surgical - Product Code LRP
• 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
• Code Information: 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 MNS1500 JOINT ASPIRATION KIT 2018101790 MNS1500 JOINT ASPIRATION KIT 2018100990 MNS1545 LATEX FREE NASAL HEMORRHAGE SET 2019030690 MNS1555 EPISTAXIS TRAY 2019040890 MNS1900 NOSEBLEED TRAY 2019040390 MNS1990 NASAL KIT 2018101290 MNS2105 EPISTAXIS TRAY 2019012890 MNS2170 NASAL PACKING TRAY 2018100890 MNS2225B MYELOGRAM TRAY 2019050790 MNS2225B MYELOGRAM TRAY 2019041090 MNS2845 U/S, BASIC BIOPSY TRAY 2019012590 MNS2975 ENT EPISTAXIS TRAY 2018121890 MNS3345A PEDIATRIC CUTDOWN TRAY 2019011490 MNS3450 IUD TRAY 2019051490 MNS3490 CHEMO KIT 2019041190 MNS3925 OB INSTRUMENT TRAY 2019040390 MNS4090A MINOR CUTDOWN TRAY 2018112690 MNS4110 THORACOTOMY TRAY 2019041690 MNS4120 NOSEBLEED TRAY 2019011690 MNS4215 OR VAGINAL DELIVERY TRAY 2018121290 MNS4360 BREAST BIOPSY KIT 2018121390 MNS4405 BIOPSY DERMATOLOGY KIT 2019050790 MNS4545 NASAL TRAY 2019031190 MNS4855 WOUND EXPLORATION/DPL TRAY 2019030890 MNS5170 NEONATAL PROCEDURE TRAY 2019041290 MNS5225 RENAL BIOPSY TRAY 2019060380 MNS5272 OB DELIVERY INSTRUMENT TRAY 2019050690 MNS5410 VAG DELIVERY INSTRUMENTS 2019040190 MNS5410 VAG DELIVERY INSTRUMENTS 2018111690 MNS5425 VAGINAL DELIVERY TRAY 2018121790 MNS5511 ARTHROGRAM TRAY 2019011790 MNS5575 OB DELIVERY TRAY 2018111990 MNS5750A VAGINAL DELIVERY SET 2018111690 MNS6025 GU MEATOTOMY 2019030790 MNS6025 GU MEATOTOMY 2018092090 MNS6260 BIOPSY TRAY 2019031990 MNS6285 MINOR PLASTIC SET 2019041790 MNS6395 VAGINAL DELIVERY KIT 2019021290 MNS6405 MULTI-PURPOSE RADIOLOGY TRAY 2019022090 MNS6820 RADIOLOGIST SPINAL TRAY 2018101590 MNS6880 BIOPSY TRAY 2019011690 MNS6985 PERCUTANEOUS CATHETER PLACEMENT TRAY 2019042390 MNS7155 TONGUE TIE KIT 2018102290 MNS7285 BIOPSY KIT- SHAVE 2019030190 MNS7285 BIOPSY KIT- SHAVE 2019012990 MNS7285 BIOPSY KIT- SHAVE 2018121090 MNS7295 BIOPSY KIT - SHAVE/PUNCH COMBO 2019030690 MNS7325 CATHETER REMOVAL TRAY 2019021990 MNS7415 NASAL HEMORRHAGE TRAY 2019012990 MNS7415 NASAL HEMORRHAGE TRAY 2018102590 MNS7575 MINOR TISSUE TRAY 2019012390 MNS7605 BREAST BIOPSY KIT 2018100890 MNS7815 DERMAL PACK 2019011690 MNS7900 C.T. BIOPSY TRAY 2019012890 MNS8010 EPISTAXIS TRAY 2019010790 MNS8445 SPINAL TRAY 2018102290 MNS8445 SPINAL TRAY 2018101190 MNS8475 ED TRACHEOTOMY TRAY 2018121390 MNS8645 BIOPSY KIT 2019042690 MNS8645 BIOPSY KIT 2019042390 MNS8915 BLOOD CULTURE COLLECTION KIT ; CVAD 2019012490 MNS9005 CENTRAL LINE REMOVAL TRAY 2019021390 MNS9106 ULTRASOUND BIOPSY TRAY 2018101190 MNS9106 ULTRASOUND BIOPSY TRAY 2018092190 MNS9170 CUTDOWN TRAY 2019032990 MNS9245 PACEMAKER TRAY 2019052490 MNS9335 IUD TRAY 2018110190 MNS9455 VAGINAL DELIVERY TRAY W/INSTRUMENTS 2019012190 MNS9480 VAGINAL DELIVERY TRAY 2019012290 MNS9480 VAGINAL DELIVERY TRAY 2018121090 MNS9625 TRACHEOSTOMY KIT 2018100590 MNS965 AMNIOCENTESIS TRAY 2019030490 MNS9710 IUD TRAY 2019011790 MNS9765 PORT INSERTION TRAY 2018100890 MNS9780 ARTHROGRAM TRAY 2018112190 MNS9820 OB PACK 2019011690 MNS9835 VAG DELIVERY TRAY 2019032990 MNS9835 VAG DELIVERY TRAY 2019020890 MNS9855 PACEMAKER INSTRUMENT TRAY 2019020690 MNS9870 DR. NELSON MOHS PACK 2019080580 MNS9870 DR. NELSON MOHS PACK 2019061080 MNS9935 CATH LAB INSTRUMENT KIT Y 2019013190
• 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.