FDA (Devices) recall action 72992
The FDA (Devices) publishes a recall like this one as 100 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 100 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 900 Universal Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 42 Laminectomy Packs due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Customed, Inc. is recalling 60 units of Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 84 laparoscopy-colorectal surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 111 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 280 surgical packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 24 neurosurgery packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 597 laparotomy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling specific lots of surgical gowns because the sterilization process and package integrity were not adequately validated.
Customed, Inc. is recalling 120 units of Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 12 units of D&C Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 152 Basic Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 85 Premium Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 36 units of Laparoscopy-Gyn Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 15 units of Labor and Delivery Surgical Packs due to inadequate sterilization validation and package integrity concerns.
Customed, Inc. is recalling 153 Ortho-Implant Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 270 units of medical leggings used in surgical procedures due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Wound Manage II kits due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 48 Cesarean Section Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 125 sterile surgical towels distributed in Puerto Rico because the sterilization process and package integrity were not adequately validated.
Customed, Inc. is recalling 42 shoulder arthroscopy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Universal Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 9,000 Suture Removal Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 144 units of Lap-Cholecystectomy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 30 units of PERI-GYN Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.