FDA (Devices) recall action 69448
The FDA (Devices) publishes a recall like this one as 179 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 179 pages.
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes (QSR) and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Customed, Inc. is recalling 92 units of Femoral Packs (catalog #900-2164) due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 420 O.B. Packs (Catalog 900-645) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 2,520 surgical gowns because compromised sterility and inadequate storage conditions may increase the risk of patient infection.
Customed, Inc. is recalling 740 Peri Gyn Packs because compromised sterility and inadequate storage conditions may result in patient infection.
Customed, Inc. is recalling 36 Hip Orthopedia Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 270 Femoral Packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
Customed, Inc. is recalling 185,000 surgical packs distributed in Florida, New York, and Puerto Rico because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 28 units of Laparoscopy Premium Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling specific lots of Surgeon Gown Poly Reinforced Lgc because compromised sterility and inadequate storage conditions may increase the risk of patient infection.
Customed, Inc. is recalling 490 Cesarean Packs (Catalog # 900-660) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 1,500 Foley Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 9,770 Foley Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 440 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling surgical gowns due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 120 Strabismus And Plastic Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling 204 Transverse Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 80 OB Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 352 Labor & Delivery Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Surgeon Reinforced Gowns XL because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling Irrigation Trays with Bulb Syringes because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 260 Cesarean Packs (Catalog 900-410) due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 344 Labor & Delivery Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 1,120 units of Gown Fabric Reinforced XXL due to compromised sterility and manufacturing deficiencies that may result in patient infection.