Recalls

At extremely high blood glucose levels (1024 mg/dL and above), the OneTouch® Verio®IQ Meter will not provide a warning and will shut off… so the company is recalling it.

The FDA has issued its highest classification of recall for the Symbios Medical GOPump Elastomeric Infusion PumpKit with and without accessories all containing Dual GOPump, part number 510076. There is a risk that the flow restrictor bead could become dislodged, resulting in a high rate of flow.

Israeli device company Lumenis Limited is recalling certain models of VersaCut Morcellator devices because of the potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing.

The FDA has issued a Class I recall of DePuy’s LPS Diaphyseal Sleeve the company having found that the Sleeve to its Base taper connection may not be sufficient to accommodate potential physiologic loads under some circumstances.

Yet again it’s registry data that has provoked a recall, this time of DePuy’s erstwhile Adept modular femoral component, which forms part of the all metal system originally sourced from Finsbury Orthopaedics Ltd.

St.Jude’s Amplatzer PFO device has its own dedicated delivery system, called Amplatzer “TorqVue”. It seems there is a problem with the core wire on certain batches, all of which are now subject to an FDA class I recall.

The FDA has seen fit to publicise GE Healthcare’s Class I recall of its T-piece circuit used with its Giraffe and Panda resuscitation units. Customers have been advised not to use the identified parts, although no patient has yet suffered injury as a consequence of device performance.

Zimmer Spine, Inc. is initiating a voluntary worldwide recall of all 315 units of the PEEK Ardis® Inserter because of reports of implant breakage when the implant is subjected to excessive lateral and/or off-axis forces from the inserter during surgery.

Ethicon, a division of J&J, has identified an issue in the packaging process for its SurgiFlo haemostatic matrix. It seems certain products, manufactured between September 16 2011 and July 27 2012 are susceptible to a potential breach of the double Tyvek pouch of the packaging.

U.S. device company Bracco Diagnostics has issued a voluntary Class I recall of its Isovue® (iopamidol injection) Pre-Filled Power Injector Syringes. It seems particles have been found in certain lots, with the obvious concern about stroke risk should any of these find there way into the cerebral vasculature.

Ethicon endo’s voluntary recall of certain Proximate Circular staplers during the summer has turned in to an FDA Class I recall due to the serious consequences that can befall the patient in whom the stapler has not completely fired.

On June 5, 2012, Stryker initiated a Class 1 recall of the Neptune Waste Management System. Now that recall has been expanded to other iterations of the device because it appears they have been marketed without 510(k) clearance which FDA deems necessary in order to establish their safety and efficacy.

Certain of Covidien’s Shiley, reusable cannula, cuffed trachoestomy tubes appear to have leakage and disconnection issues, which has lead to the UK’s MHRA issuing a Medical Device Alert.

Respironics California, Inc., a division of Philips Healthcare has completed notifying its U.S customers of a voluntary recall of 116 Respironics V60 Ventilators in the country and has confirmed that 33 have already been updated.

This time it’s the company’s Alaris drug pump, certain models of which are suffering gremlins sufficiently dangerous to warrant FDA issuing a Class 1 recall, implying there is a significant risk of adverse health consequences or death.

Covidien has announced that it is not only recalling all production lots for the Duet TRS™ Universal Straight and Articulating Single-Use Loading Units (SULU), but is in fact discontinuing the products.