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 15 packs of NEURO PACK 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 580 wound management kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 56 units of Central Line Full Body Drapes due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 92 C-Section Kits due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Customed, Inc. is recalling sterile medical products used for surgical and patient care procedures in Puerto Rico due to inadequate sterilization validation and package integrity.
Customed, Inc. is recalling Open Heart Trays due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 300 Labor and Delivery kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 507 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 8,300 suction catheter kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 123 Neuro Spine Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Fanfold Drapes due to inadequate validation of sterilization processes and package integrity, posing a potential risk of infection.
Customed, Inc. is recalling 20 units of Endoveneous Custom Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 130 packs of Urology Customed Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 2,142 units of Laparotomy Packs 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 39 sterile hip and knee replacement kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
Customed, Inc. is recalling 21 units of Retina Pack 7/CS distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 80 units of Peri Gyn Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 300 cases of O.R. Towels distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling 81 orthopedic implants distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 112 units of Laparoscopy GYN PK CS/4 kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 339 packs of Laparoscopy PK 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Major Lap Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 370 units of Angiography Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 2,180 Skin Staple Remover Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.