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 different 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- || (25) SPONGE LAP PREWASH 18" X 18" XRD L/F || (1) TRAY PLATO LARGE || (3) DRESSING NON ADH TELFA 8 X 3 || (2) BAG GLASSINE PLAIN || (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF || (1) COVER TABLE REINFORCED 50" X 90" LIF || (1) NEEDLE HYPODERMIC 27G X 'h" || (4) COUNTER NEEDLE & BLADE 10c MAG/CLEAR || (2) SYRINGE 20cc WITHOUT NDL LUER LOCK LIF || (1) JAR 16oz 500cc GRADUATE MEASURE || (2) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F || (2) PENCIL CAUTERY HAND SWITCHING LIF || (1) MARKER SKIN RULER || (2) BANDAGE ELASTIC 4" X 5yds LIF || (2) POLISHER CAUTERY TIP LIF || (2) BANDAGE ELASTIC 6" X 5yds LIF || (2) SYRINGE BULB 60cc CLEAR || (2) TUBE SUCTION CONNECT Y-t'' X 12' LIF || (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF || (1) NEEDLE BLADE/KNIFE 3.0mm || (2) CONTAINER SPECIMEN 40z. WITH LID & LABEL || (1) BLADE SHARP ALL ARROUND || (1) BASIN EMESIS 10 IN 700cc || (3) CATHETER 20FR ROB NEL RED RUB || (3) BOWL UTILITY QUART 32oz LIF || (2) CATHETER THORACIC 32FR STRAIGH || (1) LABELS SET, HEPARINE, SALINE, ETC. || (2) SAFETY SCALPEL #10 DISP || (3) BASIN WASH ROUND 6QT (2) SAFETY SCALPEL #15 DISP || (2) BOWL UTILITY 16oz L/F || (1) WRAPPER 54" X 54" L/F || (1) CONNECTOR Y 3/8" X 3/8" X 3/8" || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents