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
C-SECTION SURGICAL PACK- || (1) COVER TABLE REINFORCED 50" X 90" || (2) TOWELS ABSORBENT 15" X 20" || (1) MAYO STAND COVER REINFORCED || (1) BABY BLANKET PRINTED || (1 0) LAP SPONGES PREWASH 18" X 18" XRD || (1) BOWL PLASTIC WITH LID 80oz. || (1) BAG GLASSINE || (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR || (1) CORD UMBILICAL CLAMP || (2) LIGHT GLOVE || (1) BOWL UTILITY 32oz || (1) BOWL UTILITY 16oz || (4) DRAPE UTILITY || (1) TUBE SUCTION CONNECT. 1!4" X 12' || (1) TIP CAUTERY POLISHER || (1) MUCUSTRAP 20cc, 10FR. || (2) DRAPE SHEET 41" X 58" SMS || (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE || (1) PENCIL CAUTERY ROCKER SWITCH || (1) ELECTRODE DUAL DEPRES./GROUNDPAD || (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" || (1) EAR ULCER SYRINGE 2oz || (1) BABY BEANNIES || (1) RECEIVING BLANKET 100% COTTON || (2) SURGICAL BLADE #10 STAINLESS STEEL || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.