FDA (Devices) recall action 71721
The FDA (Devices) publishes a recall like this one as 170 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 170 pages.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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 24 Tummy Tuck & Breast Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Customed, Inc. is recalling sterile gauze sponges due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 106 Open Heart Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling cataract packs distributed in Puerto Rico because the company could not adequately validate the sterilization processes and package integrity for these sterile products.
Customed, Inc. is recalling 130 units of Peri Gyn Packs in Puerto Rico because sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling 15 packs of NEURO PACK 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 1,072 units of Laparotomy Kits due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 675 Minor Laparotomy Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling polyreinforced surgical gowns due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 320 units of Femoral Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 95 packs of laparoscopic OB GYN kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 370 units of Angiography Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 80 units of Peri Gyn Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 10 units of Shoulder Arthroscopy Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 16 units of Face Packs in Puerto Rico because the sterilization process and package integrity were not adequately validated.
Customed, Inc. is recalling 536 Arthroscopy Surgical Packs 4/C distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 450 Urology Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 525 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 115 units of Arthroscopy PK L/F 5/CS due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 48 Pediatric Lap Packs distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.