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 1,068 Angiography Packs due to significant compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 150 Premium Cesarean Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 300 Orthopedic Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Customed, Inc. is recalling 20 units of Face Lift products (Catalog 900-3083) due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 207 Neuro Spine Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 660 Carpal Tunnel Surgical Large Packs due to compromised sterility and manufacturing deficiencies that 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 240 impervious gowns 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 100 units of medical kits (Catalog # 900-913) 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 9,200 Incision & Drainage Trays because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling Wound Management Tray III units because compromised sterility and manufacturing deficiencies may result in 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 96 Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 120 OB Packs used for wound care due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling Wound Closure Tray I units because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.
Customed, Inc. is recalling Skin Staple Removal devices (Catalog 900-782) because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 212 Angiography Packs (Catalog 900-2038) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 128 Cysto Tur Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 400 units of Laparotomy Pack 1 (2 & 3) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 60 Hair Restoration Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling six ACDF Packs (catalog #900-2917) due to compromised sterility and manufacturing deficiencies that may result in 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 2,520 Laparotomy Packs (Catalog 900-176) because compromised sterility and inadequate storage increase the risk of patient infection.