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 six Tummy Tuck & Liposuction Packs due to compromised sterility and manufacturing deficiencies that pose a risk of patient infection.
Customed, Inc. is recalling 105 Plastic Surgery Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 944 Minor Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling medical leggings used for patient care procedures because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.
Customed, Inc. is recalling 75 units of Cysto Tur Pack (Catalog 900-430) due to compromised sterility and manufacturing deficiencies that may cause 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 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 63 Breat Pack-TPSC units due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Customed, Inc. is recalling 222 Urology Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 200 units of Cystoscopy Pack III due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 224 OB Packs used for patient care procedures due to compromised sterility and inadequate storage conditions 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 105 Laparoscopy OB GYN Packs due to compromised sterility and manufacturing deficiencies that may result in 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 96 Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 76 Cesarean Packs 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 Tracheotomy Care Kits due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling 129 medical devices due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 106 Open Heart Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of 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 600 C-Section Surgical Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 168 Extremity PACKs due to compromised sterility and manufacturing deficiencies that may result in 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 156 Laparoscopy Packs (Catalog 900-1176) due to compromised sterility and manufacturing deficiencies that may result in patient infection.