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
Obstetrical kit - Product Code OKV
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
Customed LABOR & DELIVERY PACK - Includes: || (1) TABLE COVER 44" x 90" || (2) LEGGINS WITH/7" CUFF 30" x 42" || (5) ABSORBENT TOWELS 15" x 20" LIF || (1) BABY BLANKET PRINTED LIF || (2) PAD OBSTETRICAL XLGE LIF || (1) EAR ULCER SYRINGE 2oz. LIF || (1) BABY BLANKET POLY ABS. IMP. LIF || (1) Pr. SURGICAL GLOVE # 7Y2 || (1) UNDER BUTTOCK DRAPE WITH POUCH || (1) BEANNIES BABY LIF || (1) FEEDING TUBE 8 Fr. 15" LONG LIF || (1) ABDOMINAL DRAPE WITH TAPE L/F || (1) DRAPE SHEET 41 " X 58" SMS || (1) GOWN SURG. REINFORCED X-LARGE SMS LEVEL IV || (1) VAGINAL SPONGE XRD || (1) UMBILICAL CORD CLAMP LIF || (2) CLOTH HUCK TOWELS BLUE || (1 0) GAUZE SPONGE 4" X 4"16 PLY XRD LIF || (1) SYRINGE 1 Occ WITH NEEDLE 21 X 1 Y2 || (1) MUCUSTRAP 20cc 1 OFr. || (1) BOWL PLASTIC 80oz WITH LID || (1) WRAPPER 24" X 24" LIF || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents