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
General surgery tray (kit) - Product Code LRO
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
Face Lift , Code 900-3083, contains: || (I) SHEET ENT SPLIT 110" X 77" LIF || (I) COVER TABLE REINFORCED 50" X 90" LIF || (I) DRAPE HEAD WITH TAPE 44" X 26" LIF || (I) COVER MAYO STAND REINFORCED LIF || (I) BAG SUTURE FLORAL LIF || (3) GOWN STANDARD LARGE SMS VEL/NE || LABEL SAMPLE || (I) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF || ( I) STAPLE SKIN 35 WIDE LIF || ( I) TUBE SUCTION CONNECT W' X 12' L/F || ( I) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (2) BLADE # I5 CARBON RIB || ( I) NEEDLE SPINAL ANEST22G X 3\12 LIF || ( I) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE 8.0 POWDER FREE LIF || (2) *PR. GLOVE SURG. 6.5 POWDER LATEX || (I) GUT PL FAST ABSORB 5-0 || (2) SUTURE 2.0 VICRYL 25MM || (3) TOWELS ABSORBENT 15" X 20" LIF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.