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 HIP Ortho. Packs due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Customed, Inc. is recalling 152 units of Femoral Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 508 packs of Premium Laparotomy Packs in Puerto Rico 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 12 units of Shoulder Packs (I) (2) due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Universal Packs used for surgical procedures due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 2-inch by 2-inch gauze pads because of inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 75 units of Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 192 packs of Angiodrape PK 4/CS in Puerto Rico 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 248 units of sterile surgical kits in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling 16 units of Face Packs in Puerto Rico because the sterilization process and package integrity were not adequately validated.
Customed, Inc. is recalling 180 surgical gowns distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 1,084 packs of Major Laparotomy Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 148 Extremity Arm Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 1,248 wound management trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 130 units of Peri Gyn Packs in Puerto Rico because sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling Arthroscopy Packs due to inadequate validation of sterilization processes and package integrity for products released as sterile.
Customed, Inc. is recalling 320 lap-cholecystectomy surgical packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 96 units of Cesarean Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 264 laparotomy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 48 units of CESAREAN PK 4/CS surgical kits 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 78 units of Laparoscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 244 laparoscopy kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.