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 differ 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
O.B. PACK - || ( I) PVP SCRUB 8" STICK SPONGES || ( I) UNDERBUTTOCK DRAPE WITH POUCH || (2) LEGGINS WITH 7" CUFF 30" x 42" || ( I) DRAPE ABDOMINAL WITH TAPE LIF || ( I) VAGINAL PACKING SPONGEXRD || ( I) BOWL WITH LID PLASTIC 80oz || ( I) RECEIVING BLANKET 100% COTTON || (I) BABY BLANKET POLY ABSORBENT IMPERVIOUS || (I) CORD UMBILICAL CLAMP || (4) TOWELS ABSORBENT 15" x 20" LIF || ( I) UTILITY BOWL 16oz. || (2) TRAY ORGANIZER FULL DEEP || (3) T IP ABSORBENT APPLICATOR || (2) GLOVES EXAM MEDIUM || (2) GOWN LARGE SMS IMPERVIOUS REINFORCED || (10) GAUZE SPONGE 4" X 4" 12PLY || (2) PAD OBSTETRJCAL X-LARGE ST. || (I) EAR ULCER SYRINGE 2oz. LIF || (I) BABY BEANNIES || (2) SHEET DRAPE 4 1" x 58" SMS LIF || (I) SCISSORS UMBILICAL || (I) TABLE COVER REINFORCED 50" x 90" LIF || (2) WRAPPER 24" X 24" L/f || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.