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 - - || (7) TOWELS ABSORBENT 15" X 20" || (2) SCALPEL WEIGHTED SAFETY #1 0 || (1) BLANKET BABY 30" X 30" POLY ABS IMP || (1) BOWL UTILITY QUART 32oz. || (1) TUBE FEEDING 8Fr. 15" LONG || (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR || (1) BEANNIES BABY || (2) PAD OBSTRETICAL XLGE ST. || (1) SYRINGE 20cc W/0 NEEDLE LIL || (1) SYRINGE EAR/ULCER 2oz. || (1) BLANKET RECEIVING 100% COTION || (1) CLAMP UMBILICAL CORD ST. || (1) COVER TABLE REINFORCED 50" X 90" || (1) SYRINGE 10CC W/0 NEEDLE L/LOCK || (1) BOWL PLASTIC W/LID 80oz || (2) GOWN XL SMS IMPERVIOUS REINFORCED || (1) SHEET DRAPE 41" X 58" SMS || (1) DRAPE C SECTION W/POUCH 102" X 121" X 78" || (1) YANKAUER SUCTION TUBE W/0 VENT || (1) WRAPPER 30" X 30" || (15) SPONGE LAP PREWASH 18" X 18" XRD || (1) TIME OUT BEACON NON WOVEN ST. || (1) TUBE SUCTION CO NN ECT~" X 12' || (2) LIGHT SHIELD || (1) GOWN SURG REINF LARGE T/WRAP || (2) PK. STRIP STERI CLOSURE W' X 4" || (1) POLISHER CAUTERY TIP || (1) DRESSING COMP OP 4" X 14" || (1) COVER MAYO STAND REINFORCED || (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents