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 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
LAPAROSCOPY CHOLE SYSTEM PACK || MIAMI METRO || CON TENTS: || (12) TOWELS CLOTH HUCK BLUE LIF || (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SUTURE BAG FLORAL LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF || (1) BLADE SURGICAL #10 STAINLESS STEEL || (2) SHEET% 60" X 77" DRAPE REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF || (1) BLADE SURGICAL #15 CARBON STEEL (1) TUBE SUCTION CONNECT Y." X 12' LIF (1) BAG GLASSINE PLAIN || (1) CAUTERY TIP POLISHER LIF || (1) DRAPE LAP. ABDOMINAL WITH POUCH 102" X 122" X 78" LIF (1) PK. STRIP STERI CLOSURE W' X 4" LIF || (1) SKIN MARKER INK WITH 8/LABEL/TIME OUT/RULER L/F (1) CORD LAPAROSCOPY MONOPOLAR FOOD SWICHING (1) COUNTER NEEDLE BLADE 30c MAG/FOAM || (1) TIME OUT BEACON NON WOVEN LIF || (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF || (1) GOWN SURG. REINFORCED X LARGE TOWEL/WRAP LIF (1) TOWEL ABSORBENT 15" X 20" LIF || (1) BLADE SURGICAL #11 CARBON STEEL || (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT LIF (1) YANKAUER OPEN TIP CLEAR WITHOUT C IV LIF || ATTACHED PACK WITH THE FOLLOWING STERILE COMPONENT: (1) ACTIFOG WITH/FOAM PAD SOLUTION LIF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.