U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
조치
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
제품 설명
OPEN HEART TRAY || PACK A || CONTENTS: || (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F || (3) TOWEL ABSORBENT 15" X 20" LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SPLIT SHEET BILATERAL 84" X 80" || (12) % SHEET 60" X 77" DRAPE REINFORCED LIF (1) MAYO TRAY LARGE || (1) CV DRAPE SPLIT CARDIO WITH CLEAR ANEST. SC STD SMS (15) TOWELS CLOTH HUCK BLUE || (4) TOWELS CLOTH HUCK WHITE || (2) STOCKINETTE IMPERVIOUS 14" X 48" LIF (30) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) WRAPPER 54" X 54" || (3) LITES GLOVE LIF || OPEN HEART TRAY || HOSPITAL HERMANOS MELENDEZ || PACKB || CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF || (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (2) CATHETER THORACIC 32FR. STRAIGH || (2) PENCIL CAUTERY ROCKER SWITCH LIF || (3) TUBE SUCTION CONNECT W X 12' LIF || (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) LABEL SET, HEPARINE SALINE || (2) CAUTERY TIP POLISHER LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF (1) BANDAGE ELASTIC 6" X 5yds LIF || (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF || (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST. || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (1) NEEDLE HYPODERMIC 27G X %" ST. || (1) NEEDLE & BLADE COUNTER 60C MAG/MAG (2) BOWL UTILITY 16oz. || (4) FEEDING TUBE 8FR, 15" LONG (2) BULB SYRINGE 60cc || (1) TRAY PLATFORM LARGE || (1) SKIN MARKER WITH RULER || (1) CATHETER 18FR SUCTION W/STRA LIF (1) WRAPPER 54" X 54" UF || (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (2) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #20 CARBON STEEL || OPEN HEART TRAY || HOSPITAL HERMANOS MELENDEZ || PACKC || CONTENTS: (9) TOWELS ABSORBENT 15" X 20" UF || (6) GOWN FAB REINFORCED SONTARA X-LARGE || (1) GOWN IMPERVIOUS XTRA REINFORCED X-LARGE TOWEL & WRAP LEVEL Ill || (1) TABLE COVER REINFORCED 44" X 78" UF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.