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 840 Major Laparotomy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 71 Open Heart Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 51 Transforaminal Lumbar Interbody Fusion (TLIF) packs because compromised sterility and manufacturing deficiencies may lead to 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 600 C-Section Surgical Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 236 units of Femoral Angiography Packs due to compromised sterility and manufacturing deficiencies that may cause 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 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 six Tummy Tuck & Liposuction Packs due to compromised sterility and manufacturing deficiencies that pose a risk of patient infection.
Customed, Inc. is recalling 84 Retina Packs because compromised sterility and inadequate storage conditions may result in 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 180 Arthroscopy Packs (Catalog 900-1042) because manufacturing and storage deficiencies compromised sterility, posing a risk of 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 Utility Drape End Products due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 140 ENT Packs due to compromised sterility and manufacturing deficiencies that may result in 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 36 orthopedic trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 176 O.B. Packs due to compromised sterility and manufacturing deficiencies that 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 20 Liposuction 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 480 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 335 Premium OB Packs because compromised sterility and inadequate storage conditions 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.