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
laparoscopy kit - Product Code FDE
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
LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - || (1) DRAPE LAPAROS/ABDOMINAL UF || (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP || (1) BLADE SURGICAL #11 STAINLESS STEEL || (1) TIME OUT BEACON NON WOVEN UF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF || (1) GOWN XLARGE SMS IMPERV. REINFORCED || (3) TOWEL ABSORBENT 15" X 20" UF || (1) TUBBING INSUFFLATION SET WITHOUT RING || (1) MAYO STAND COVER REINFORCED UF || (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG UF || (1) TABLE COVER REINFORCED 50" X 90" UF || (1) SKIN MARKER INKW/8LABEUTIME OUT/RULER || (1) DRAPE SHEET 41 " X 58" SMS UF || (1) BAG SUTURE FLORAL || (4) DRAPE UTILITY UF || (1) TUR CYSTO IRRIGATION SET 79" SINGLE UF || (1) TUBE SUCTION CONNECT. 3/16 " x 12' UF || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.