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 138 laparoscopy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Laminectomy Pack 3/C units in Puerto Rico 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 125 O.B. Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 874 C-Section Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 210 units of knee and hip replacement devices distributed in Puerto Rico due to inadequate sterilization validation 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 Tummy Tuck Packs due to inadequate validation of sterilization processes and package integrity.
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 354 units of Laparoscopy-Colorectal Surgical Packs distributed in Puerto Rico due to inadequate sterilization validation 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.
Customed, Inc. is recalling 95 packs of laparoscopic OB GYN kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 12 Lumbar Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 540 units of Mayo Stand Covers 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 surgical gowns due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Customed, Inc. is recalling Minor Laceration Trays because the sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling 3,000 units of gauze sponges due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 1,350 Wound Closure Tray II units in Puerto Rico 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 Pery-Gyn Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 147 units of O.B. Pack Hospital 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Angiodrape Packs in Puerto Rico because sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling 216 units of Cool Impervious XLGE Breathable surgical gowns due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 155 Urology Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.