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
Cesarean section kit - Product Code OHM
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
CESAREAN PACK - || (1) BABY BLANKET IMP. 30" X 30" POLY ABS. || (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF || (1) DRESSING ISLAND 4" x 10" || (1) CESAREAN DRAPE 71" x 125" LIF || (2) GOWN SURG REINFORCED LARGE TOWEL/WRAP || (10) LAP SPONGES PREWASH XRD LIF || (1) BABY BEANNIES || (1) SCALPEL #10 WITH HANDLE STAINLESS STEEL || (1) DRAPE SHEET 42" X 57" SMS || (1) EAR ULCER SYRINGE 2oz. UF || (1) RECEIVING BLANKET 100% COTTON || (1) SCALPEL #20 WITH HANDLE || (1) DURAPREP SURGICAL SOLUTION 26ml UF || (2) ABSORBENT TOWEL 15" X 20" L.F || (2) LITE GLOVES UF || (1) BOWL WITH LID PLASTIC 80oz. || (1) TABLE COVER REINFORCED 44" x 78" LIF || (1) UTILITY BOWL 32oz || (2) PAD OBSTETRICAL X-LARGE ST. || (1) WRAPPER 30" X 30" LIF || (1) MAYO STAND COVER REINFORCED LIF || (1) TUBE SUCTION CONNECT Y." X 12' UF || (1) MUCUSTRAP 20cc 1 OFR || (1) YANKAUER SUCTION TUBE WITHOUT VENT UF || (1) UMBILICAL CORD CLAMP || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.