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 24 femoral surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 140 Cystoscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 16 Arthroscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 30 units of Basic Surgical Pack IV in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 150 Lithotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 76 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 47 Open Heart Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 10 Basic Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Wound Closure Tray I units due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 44 Labor and Delivery Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 55 Basic Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 162 carpal tunnel surgical packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Customed, Inc. is recalling 1,920 fan fold sheets distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 2,450 Urethral Catheter Trays (14FR) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 580 sterile skin staple removers distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 200 Wound Management Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 800 units of Utility Drapes with Tape, SMS, due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 25 arthroscopy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 344 Minor Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 620 Wound Management Tray III units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 5,650 Suction Catheter Trays 14FR with Sodium Chloride 0.9% Irrigation because of inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 72 Cysto TUR Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 25 units of Urology Surgical Packs (Catalog No. 9001738) due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 800 Incision and Drainage Trays due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 45 Premium Cesarean Packs due to inadequate validation of sterilization processes and package integrity.