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 490 Cesarean Packs (Catalog # 900-660) due to compromised sterility and manufacturing deficiencies that may result in 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.
Customed, Inc. is recalling 400 units of Basic Pack 1 (III) due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 70 Angiography Packs (Catalog 900-1488) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 250 Minor Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling Tracheotomy Care Kits due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling 1,152 Angiodrape Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 126 shoulder packs used for wound care 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 162 units of Peri Gyn Packs because compromised sterility and manufacturing deficiencies may result in 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 36 Hip Orthopedia Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling Universal Drainage Trays because compromised sterility and manufacturing deficiencies 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 144 Knee Arthroscopy Packs because significant sterility compromises and manufacturing deficiencies 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 288 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling Wound Closure Tray II units due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 114 Neuro Packs (catalog #900-2256) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 36 units of Laparoscopy Chole Packs 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 204 Transverse Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 122 C-Section Packs due to compromised sterility and manufacturing deficiencies that may result in 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 400 Laparotomy Pack III units due to compromised sterility and manufacturing deficiencies that may cause patient infection.