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 413 units of Shoulder Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Pery-Gyn Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 120 units of laparoscopic cholecystectomy kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
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 130 packs of Urology Customed Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 639 Ortho-Implant Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 32 laparoscopy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 24 units of Face Pack MRT due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 540 surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 327 units of Shoulder Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 130 angiography kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 244 units of Femoral Angiography Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 20,200 Suture Removal Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 388 angiography kits distributed in Puerto Rico 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 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 508 packs of Premium Laparotomy Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 132 O.B. Packs distributed in Puerto Rico 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 1,452 units of Minor Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Minor Laceration Trays because the sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling 24 units of Breast Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 48 umbilical vessel catheter kits 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 123 Neuro Spine Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.