Customed Recalls
682 recalls on record · September 10, 2014 to April 20, 2016 · Medical Devices
Recalls by year
14
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Angiodrape Pack, Catalog number 900-002. Used by medical staff to perform patient care procedures such as wound heali
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medical staff to perform patient care procedur
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to perform patient care procedures
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Gown Fabric Reinforced XXL, Catalog number 900-2567. Used by medical staff to perform patient care procedures such as
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical staff to perform patient care procedures s
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by medical staff to perform patient care proce
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Gown Surg Fully Impervious Large, Catalog number 900-2564. Used by medical staff to perform patient care procedures s
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Wound Management Tray, Catalog number 900-1903. Used by medical staff to perform patient care procedures such as woun
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staff to perform patient care procedures such a
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Minor Laceration Tray, Catalog number 900-1765. Used by medical staff to perform patient care procedures such as woun
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient care procedures such as wound
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by medical staff to perform patient care procedur
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to perform patient care procedures su
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as w
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Wound Management Tray, Catalog number 900-1154. Used by medical staff to perform patient care procedures such as woun
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient care procedures such as wound h
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to perform patient care procedures such as wo
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Utility Drape End Product, Catalog number 900-582. Used by medical staff to perform patient care procedures such as w
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform patient care procedures such as w
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical staff to perform patient care procedures su
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform patient care procedures such as wou
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Suction Catheter Kit, Catalog number 900-277. Used by medical staff to perform patient care procedures such as wound
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such as wound
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Wound Closure Tray II, Catalog number 900-064. Used by medical staff to perform patient care procedures such as wound
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Wound Closure Tray I, Catalog number 900-063. Used by medical staff to perform patient care procedures such as wound
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Universal Drainage Tray, Catalog number 900-032. Used by medical staff to perform patient care procedures such as wou
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical staff to perform patient care procedures s
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
December 10, 2014Medical DevicesFDA
Customed, Inc recalls Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound
Hazard: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes (QSR) and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
September 10, 2014Medical DevicesFDA
Customed, Inc recalls Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 20" (1) GOWN LARGE STANDARD SMS VELCRO NECK
Hazard: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.