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 200 Arthroscopy Packs (catalog #900-2473) due to compromised sterility and manufacturing deficiencies that may cause 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 1,152 Angiodrape Packs due to compromised sterility and manufacturing deficiencies that may result in 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 132 Neuro Packs because compromised sterility and manufacturing deficiencies 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 35 Endovenous Custom Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling 892 Laparotomy Packs (Catalog 900-149) because compromised sterility and inadequate storage conditions may result in patient infection.
Customed, Inc. is recalling 2,240 surgical gowns due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Minor Laceration Trays because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 475 Pery Gyn Packs because significant sterility compromises and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 48 Umbilical Vessel Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 160 Knee and Hip Replacement trays due to compromised sterility and manufacturing deficiencies that may increase the risk of 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 400 units of Basic Pack 1 (III) due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 60 Arthroscopy Packs 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 2,520 Laparotomy Packs (Catalog 900-176) because compromised sterility and inadequate storage increase the risk of patient infection.
Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that 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 Universal Drainage Trays because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 156 Universal Packs (Catalog 900-1587) because compromised sterility and manufacturing deficiencies may increase the risk of 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 315 Reyito Urological Packs because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.
Customed, Inc. is recalling 1,068 Angiography Packs due to significant compromised sterility and manufacturing deficiencies that may result in patient infection.