FDA (Devices) recall action 72992

Customed, Inc recalled 100 products on 2016-04-20

The FDA (Devices) publishes a recall like this one as 100 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 100 pages.

Products: 100
Announced: 2016-04-20
Critical: 0
Units: 62,224

Why these products were recalled

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.

States named across these recalls

26–50 of 100

HighFDA (Devices)··2016-04-20
Customed Neuro-Spine Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 81 Neuro-Spine Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Minor Laceration Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 3,700 Minor Laceration Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
SevereFDA (Devices)··2016-04-20
Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 15 units of Plastic Surgery Packs (Catalog Number 9001402) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Wound Closure Tray II Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 600 units of Wound Closure Tray II in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Foley Catheter Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,920 Foley catheter trays distributed in Puerto Rico due to inadequate sterilization process validation and package integrity.
Product
Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Peri-Gyn Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 30 Peri-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
SevereFDA (Devices)··2016-04-20
Customed Hip and Knee Replacement Surgical Pack Recall for Sterilization Issues
Customed, Inc. is recalling 18 units of Hip and Knee Replacement Surgical Packs due to inadequate sterilization validation and package integrity concerns.
Product
Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Cesarean Section Surgical Packs Recalled for Sterilization Defects
Customed, Inc. is recalling 96 Cesarean Section Surgical Packs due to inadequate sterilization validation and package integrity issues.
Product
Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Pery-Gyn Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 150 Pery-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Knee Arthroscopy Surgical Pack Recalled for Sterilization Defects
Customed, Inc. is recalling 12 units of Knee Arthroscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed REYITO PLUS Urology Surgical Pack Recalled for Sterilization Defects
Customed, Inc. is recalling 35 units of REYITO PLUS Urology Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Wound Management Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,088 Wound Management Trays because sterilization processes and package integrity were not adequately validated.
Product
Catalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Laparotomy Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 938 Laparotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Surgical Gowns Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 96 surgical gowns distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed ENT Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 70 ENT Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Tracheostomy Care Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,800 tracheostomy care kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Strabismus Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling eight Strabismus Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Orthopedic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 85 orthopedic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed C-Section Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 238 C-Section Surgical Packs because the sterilization processes and package integrity were not adequately validated.
Product
Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Dressing Change Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 550 Dressing Change Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Arthroscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 18 Arthroscopy Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Irrigation Trays Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 4,400 irrigation trays with bulb syringes distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Foley Catheter Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 380 units of Foley Catheter Trays in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Pery-Gyn Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 80 Pery-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state
HighFDA (Devices)··2016-04-20
Customed Recalls Sterile Mayo Stand Covers Due to Sterilization Validation Issues
Customed, Inc. is recalling 540 sterile Mayo stand covers distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Distribution
1 state