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 188 Knee Arthroscopy Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 1,050 units of Dressing Change kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 30 units of Laparotomy Basic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 77 units of Basic Packs Without Gown due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 5,500 urethral catheter trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 144 cases of impervious gowns distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 413 units of Shoulder Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 56 Open Heart Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 360 Ophthalmic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 588 units of Carpal Tunnel Large Surgical Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Customed, Inc. is recalling 192 D & C Laparoscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 115 units of PERI GYN PACK 5/CS due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 960 Universal Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 1,960 Foley Catheter Kits II 16FR distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 105 Plastic Surgery Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling EENT Pack I sterile medical packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 490 Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 50 units of Cysto Tur Pack 5/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 30 units of UROLOGY PK 5/CS kits in Puerto Rico due to 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.