Other Medical Devices Recalls

Laparoscopy Pack, Catalog number 900-1967. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

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.

Oct 8, 2014 Other Medical Devices View Details →

Open Heart Tray, Catalog number 900-1196C Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

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.

Oct 8, 2014 Other Medical Devices View Details →

Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

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.

Oct 8, 2014 Other Medical Devices View Details →

Cesarean Pack, Catalog number 900-1689. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

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.

Oct 8, 2014 Other Medical Devices View Details →

Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant 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.

Oct 8, 2014 Other Medical Devices View Details →

Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

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.

Oct 8, 2014 Other Medical Devices View Details →

Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

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.

Oct 8, 2014 Other Medical Devices View Details →

Laparoscopy Chole Pack, Catalog number 900-1688. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

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.

Oct 8, 2014 Other Medical Devices View Details →

Extremity PACK, catalog #900-2615 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant 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.

Oct 8, 2014 Other Medical Devices View Details →

Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

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.

Oct 8, 2014 Other Medical Devices View Details →

Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: " Intracranial aneurysms " Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae " Arterial and venous embolizations in the peripheral vasculature

Stryker Neurovascular

Class I - Dangerous

Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.

Oct 22, 2014 Other Medical Devices View Details →

Liposuction Pack, catalog #900-2656 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant 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.

Oct 8, 2014 Other Medical Devices View Details →

Cataract Pack, Catalog # 900-944 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant 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.

Oct 8, 2014 Other Medical Devices View Details →

Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

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.

Oct 8, 2014 Other Medical Devices View Details →

BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454

Philips Medical Systems (Cleveland)

Class I - Dangerous

Software issues

Nov 4, 2014 Other Medical Devices View Details →

AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

Vision Rt

Class I - Dangerous

Potential failure of AlignRT to assert interlock.

Oct 15, 2014 Other Medical Devices View Details →

Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.

Zimmer

Class I - Dangerous

To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.

Oct 14, 2014 Other Medical Devices Nationwide View Details →

Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5).

Synthes (USA) Products

Class I - Dangerous

Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification.

Oct 23, 2014 Other Medical Devices View Details →

Dharma Cavity Varnish 15mL

Dharma Research

Class I - Dangerous

During an FDA inspection it was found that the products are marketed without a cleared 510k.

Sep 29, 2014 Other Medical Devices View Details →

Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.

Market-Tiers

Class I - Dangerous

Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.

Jul 16, 2014 Other Medical Devices Nationwide View Details →