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 1,072 units of Laparotomy Kits due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling obstetrical surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 690 Wound Management Tray II units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 300 units of medical leggings used for surgical and patient care procedures due to inadequate sterilization validation and package integrity issues.
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 176 units of Cysto Tur Pack Basic due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 24 units of Face Lift medical kits 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 426 laparoscopic cholecystectomy kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
Customed, Inc. is recalling 80 Minor Procedure Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 540 surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 546 ophthalmic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 36 units of Laparoscopy OB 6/CS devices distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 177 units of Shoulder 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 specific lots of Ear Packs used in surgical procedures due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 432 Basic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 55 plastic surgery packs distributed in Puerto Rico 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.
Customed, Inc. is recalling 1,128 angiography packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 32 laparoscopy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 27 Open Heart Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 10 units of UROLOGY PK 5/CS kits in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 320 Arthroscopy PK 5/CS kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 285 units of Extremity Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.