Other Medical Devices Recalls

AUTOCOMP6 XP High Speed Compounder REF 58810

The Metrix Company

Class I - Dangerous

An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

Jun 23, 2016 Other Medical Devices Nationwide View Details →

Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.

The Metrix Company

Class I - Dangerous

An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

Jun 23, 2016 Other Medical Devices Nationwide View Details →

UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System. Catalog No. UniCel DxC 800 Synchron Clinical Systems UniCel DxC 600 Synchron Clinical Systems UniCel DxC 600i Synchron Access Integrated Clinical Systems UniCel DxC 880i Synchron Access Integrated Clinical Systems UniCel DxC 660i Synchron Access Integrated Clinical Systems Product Labeling Reference No. A93719 For the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.

Beckman Coulter

Class I - Dangerous

Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.

Apr 22, 2014 Other Medical Devices View Details →

Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.

Integra LifeSciences

Class I - Dangerous

The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.

Jul 1, 2016 Other Medical Devices View Details →

Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.

The Metrix Company

Class I - Dangerous

An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

Jun 23, 2016 Other Medical Devices Nationwide View Details →

Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL

The Metrix Company

Class I - Dangerous

An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

Jun 23, 2016 Other Medical Devices Nationwide View Details →

Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift Air 300 IRC, Molift Air 300 IRC Propulsion Molift Air is a ceiling hoist used to lift and transfer immobilized patients in various situations. The coupling that holds the suspension is fixed to the lifting belt by a bolt through an aluminum housing. The bolt is hold in place by a rubber cap secured with a small screw. The other end of the lifting belt is fixed to the lifting drum on the motor. The design is identical on both Air 205 and Air 300 in all variants

Moller Vital

Class I - Dangerous

Potential for the bolt on the suspension coupling on the Molift Air to come loose from the housing.

Jun 24, 2016 Other Medical Devices Nationwide View Details →

Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.

Tosoh Bioscience

Class I - Dangerous

Instructions For Use had incorrect lot number and calibrator values

Jun 7, 2016 Other Medical Devices Nationwide View Details →

GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.

GE Inspection Technologies

Class I - Dangerous

Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. The identified cause was insufficient attachment of shielding in the door. Jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.

Mar 2, 2016 Other Medical Devices View Details →

Container fill and transfer sets, 250 mL and 500 mL, . .

The Metrix Company

Class I - Dangerous

An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

Jun 23, 2016 Other Medical Devices Nationwide View Details →

Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL

The Metrix Company

Class I - Dangerous

An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

Jun 23, 2016 Other Medical Devices Nationwide View Details →

Endotine Transbleph 3.5 (CFD-080-0167)

MicroAire Surgical Instruments

Class I - Dangerous

MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).

May 6, 2016 Other Medical Devices View Details →

Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.

The Anspach Effort

Class I - Dangerous

The graphics at the attachment interface indicating locked and unlocked position are reversed.

Jun 15, 2016 Other Medical Devices View Details →

2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otology /Neurotology/ Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy. They are intended to be used with the Stryker CORE" system.

Stryker Instruments Div. of Stryker

Class I - Dangerous

A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk to Health: Injury to critical soft tissue requiring surgical intervention may occur.

Jun 24, 2016 Other Medical Devices Nationwide View Details →

cobas¿ Liat¿ Analyzer

Roche Molecular Systems

Class I - Dangerous

Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.

May 9, 2016 Other Medical Devices View Details →

Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero head, and will provide a maximum pressure output of 11 pounds per square inch (76,000 pascals). The Sarns TM Dual Cooler-Heater can be used with heat exchangers capable of accepting these flows and pressures. Product Usage: The Sarns Dual Cooler-Heater is indicated for use as a water supply system to a blood heat exchanger in open-heart surgery.

Terumo Cardiovascular Systems

Class I - Dangerous

Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Inter chlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.

Jun 8, 2016 Other Medical Devices Nationwide View Details →

Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.

Smith & Nephew

Class I - Dangerous

The device could be subject to breaches of its sterile packaging.

Jun 15, 2016 Other Medical Devices Nationwide View Details →

BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.

Becton, Dickinson and Company, BD Biosciences

Class I - Dangerous

One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.

Jun 24, 2016 Other Medical Devices View Details →

Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.

Amerx Health Care

Class I - Dangerous

Product did not meet specifications for Zinc Acetate (OOS).

May 20, 2016 Other Medical Devices Nationwide View Details →

The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.

Beckman Coulter

Class I - Dangerous

Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery.

Jun 27, 2016 Other Medical Devices View Details →