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 480 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 9,200 Incision & Drainage Trays because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 308 units of General Line Full Body Drapes due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 6,300 Fanfold Drapes due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 242 units of Basic Pack W/Out Gown due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 105 Ear Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 400 Arthroscopy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 92 Extremity Arm Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 2,670 surgical gowns because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.
Customed, Inc. is recalling 180 Laminectomy Packs because compromised sterility and inadequate storage conditions may result in patient infection.
Customed, Inc. is recalling 460 Lithotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 70 Laparotomy Basic Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling Suction Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 48 Cirugia Cardiovascular Case Carts due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 256 Arthroscopy Packs (Catalog 900-1062) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 230 units of Peri Gyn Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 246 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Wound Management Tray II units due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 625 Minor Laparotomy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 582 Ophthalmic Packs due to compromised sterility and inadequate storage conditions that may result in patient infection.
Customed, Inc. is recalling 1,050 Dressing Change kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 880 surgical packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
Customed, Inc. is recalling 210 Angiography Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Customed, Inc. is recalling 64 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling Mayo Stand Covers with CSR Wrap due to compromised sterility and manufacturing deficiencies that may result in patient infection.