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
laparoscopy kit - Product Code FDE
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
LAPAROSCOPY CHOLE PACK - || (6) TOWELS ABSORBENT 15" X 20" LIF || (1) MAYO STAND COVER REINFORCED L/F || (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF || (1) SURGICAL BLADE #11 CARBON STEEL || (1) TUR Y SET, 2LEAD L/F || (4) DRAPE UTILITY WITH TAPE LIF || (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) || (1) ULTRA VERES NEEDLE 120mm || (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF || (1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78" || (2) DRAPE SHEET 41" X 58" SMS || (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD L/F || (5) LAP SPONGE PREWASH XRD LIF || (1 ) DRAPE LASER CAMERA W/EL. 6" X 96" LIF || (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF || (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT) || (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF || (1) SURGICAL DURAPREP SOLUTION 26ML LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents