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
Orthopedic tray - Product Code OJH
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
FEMORAL PACK || CONTENTS: || (2) TOWELS ABSORBENT 15" X 20" LIF (2) DRAPE SHEET 42" X 57" SMS LIF || (1) SAFETY IV INTROCAN 18 X 1X ST. LIF || (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF (2) VESSEL LOOP SURGICAL MAXI BLUE || (1) SUTURE AID BOOT STD YELLOW ST. LIF || (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F || (1) EMESIS BASIN 101N 700cc LIF (2) LIGHT SHIELD || (1) NEEDLE HYPODERMIC 18G X 1 L/F (1) CATHETER IV SAFETY 20G X 1X LIF || (1) DRAPE T LAPAROT 102" X 78" X 121" SMS STD LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF || (1) MAYO STAND COVER REINFORCED LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF || (2) SYRINGE 20cc WITHOUT NEEDLE LUER I LOCK LIF (1) SUTURE BAG FLORAL LIF || (2) UTILITY BOWL 16oz. L/F || (1) CAUTERY TIP POLISHER LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF (4) DRAPE UTILITY WITH TAPE LIF || (1) MAYO TRAY SMALL || (1) SCALPEL SAFETY WEIGHTED #15 (1) SCALPEL SAFETY WEIGHTED #11 || (2) TUBE SUCTION CONNECT X" x 12' LIF || (2) NEEDLE & BLADE COUNTER, 1Oc MAG/CLEAR LIF (1) TIME OUT BEACON NON WOVEN ST. LIF || (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER L/F || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.