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 COLORECTAL SURGICAL PACK || CONTENTS: || (1) SOLUTION SURGICAL DURAPREP 26ml LIF || (4) DRAPE UTILITY WITH TAPE LIF || (3) TOWELS ABSORBENT 15" X 20" LIF || (2) LEGGINS W/7'' CUFF 30" X 42" LIF || (1) BLADE SURGICAL# 15 STAINLESS STEEL || (1) BLADE SURGICAL# 11 STAINLESS STEEL || (1) GOWN IMPERV. EXTRA REINF. XLG AAMI Ill LIF || (1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (2) UTILITY BOWL 16oz. LIF || (2) PK. STERI STRIP CLOSURE%'' X 4" L/F || (1) ACTIFOG WITH FOAM PAD SOLUTION LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) MAYO STAND COVER REINFORCED LIF || (1) NEEDLE ULTRA VERES 120MM LIF || (1) STAPLE ARTICULATING ECHEL 60MM LIF || (1) RELOAD WHITE 60MM ECHELON L/F || (2) CANNULA 5MM XCEL SLEEVES LIF || (1) TROCAR 5MM BLADELE W/STAB SLEEVE UF || (1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF || (10) LAP SPONGES PREWASH 18" X 18" XRD LIF || (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF || (2) LITE GLOVE || (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF || (1) ELECTRODE DUAL DEPRES || (1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES || (1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF || (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF || (1) BAG SUTURE FLORAL || (1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF || (1) POLISHER CAUTERY TIP LIF || (1) BAG GLASSINE || (1) RELOAD BLUE 60MM LIF || (1) TIME OUT BEACON NON WOVEN LIF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.