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.
데이터 추가 비고
General surgery tray (kit) - Product Code LRO
원인
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
UNIVERSAL PACK - || (1) TRAY ORGANIZER FULL DEEP || (1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF || (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK UF || (1) NEEDLE HYPODERMIC 20G X 1 ~ UF || (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI Ill || (1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF || (1) SHEET% 57" X 63" REINFORCED SMS LIF || (2) TOWELS ABSORBENT 15" X 20" LIF || (4) DRAPE UTILITY LIF || (1 0) GAUZE SPONGES 4" X 4" 12PL Y LIF || (4) CLOTH HUCK TOWELS BLUE LIF || (1) TABLE COVER REINFORCED 50" X 90" UF || (1) SCALPEL WITH HANDLE #11 || (1) DENTURE CUP WITH LID || (1) TRAY 2 COMPARTMENT || (2) ABSORBENT TIP APPLICATOR || (1) IMPERVIOUS STOCKINETIE 14" X 48" LIF || (1) TAPE TRANSPORE 1" X 36" || (1) DIISP NEEDLE 30 X ~ || (1) PROBE DRAPE 6" X 96 WITH GEL || (1) ARTERIAL NEEDLE 18 X 2 % || (1) CATHETER INTRODUCER 7FR || (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.