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 56 Open Heart Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 96 OB Packs CS/4 in Puerto Rico due to inadequate sterilization validation and package integrity.
Customed, Inc. is recalling 460 Pery Gyn 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 Tummy Tuck Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling surgical gowns due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 228 PERI GYN PACK CS/6 units distributed in Puerto Rico 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 1,050 Incision and Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 125 O.B. Packs distributed in Puerto Rico 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 18 units of Hair Restoration Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 64 NEURO PACK surgical kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
Customed, Inc. is recalling 45 Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 4,800 irrigation trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 290 packs of Cysto TUR Pack due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 63 units of E.N.T. PK 7/CS kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 390 packs of Premium O.B. Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 55 packs of Premium Arthroscopy PK 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.
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 138 laparoscopy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 19,328 units of 4"x4" 16-ply gauze sponges distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 6 units of Shoulder Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 33 units of Breast Pack-TPSC in Puerto Rico due to inadequate validation of sterilization processes and package integrity.