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 FWZ
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
Arthroscopy Pack,900-2609, contains: || (5) LAP SPONGE PREWASH 18" X 18" XRD || (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH || (3) STRIPS TAPE 24" X 4" || (1) U-DRAPE 60" X 70" WITH TAPE SPLIT || (4) TOWELS ABSORBENT 15" X 20" || (1) MAYO STAND COVER REINFORCED || (1) TUBE SUCTION CONNECT Y4" X 12' || (2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds || (10) GAUZE SPONGE 4" X 4" 16PLY XRD || (1) MERLING SKIN PREP. APPLIC 39ML || (1) CAST PADDING COTTON ROLL 2" X 4yds || (1) SKIN MARKER WITH RULER || (1) BLADE SURGICAL# 11 CARBON STEEL || (1) GOWN SURG REINFORCED LGE TOWEL WRAP || (2) GOWN XL SMS IMPERVIOUS REINFORCED || (2) LITE GLOVE || (1) STOCKINETTE IMPERVIOUS 12" X 48" || (1) TABLE COVER REINFORCED 50" X 90" || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.