Product Recall

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.

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.

So who dropped the ball? It looks like one of Synthes Hemostatic Bone Putty’s constituents is flammable, which makes it look like the culprit in the flammable bone putty debacle.

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.

Covidien is conducting a voluntary recall of certain production lots of the DGPHP RFA High-Power Single Use Grounding Pads and Cool-tip™ RFA Electrode Kits that contain DGPHP RFA High-Power Single Use Grounding Pads.

As is often the case a company’s voluntary recall has morphed into the FDA Class 1 variety. This time it’s Covidien’s Shiley Adult Tracheostomy Tubes which have reportedly suffered disconnection and leakage.

J&J subsidiary business Ethicon Endosurgery has issued a voluntary recall of certain lots of its PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories. The recall was provoked by reports of difficulty firing the device although the company seems to have no problem doing so when reloading returned devices.

A “Talking” Blood Glucose Meter that doesn’t talk. A sterile urinary catheter that isn’t sterile. A reprocessing unit that risks contaminating its contents. A week in the life of UK MHRA’s safety/recalls/alerts department.

Covidien has confirmed that it notified customers on July 18, 2012, about a voluntary global recall of certain lots of its Shiley™ reusable cannula, cuffed adult tracheostomy tubes, size 8. This action was in response to reports of volume leakage and/or disconnection between the inner and outer cannulae.

FDA has issued a Class I recall notice relating to Teleflex subsidiary Arrow International’s Multi-Lumen Venous Catheterisation Set, following the company’s May Field Corrective Action Letter.

Carefusion is clearly busy with recall issues, three ventilator products having suffered problems in the past year (two in the past month). the company is now updating its guidance on the Enve® recall issued in June.

Maquet is recalling certain of its Flow-i Anesthesia Systems due to a software problem which requires a fix. FDA considers the recall Class I which implies use of the product may cause serious adverse health consequences or death.

Stryker has undertaken a voluntarily global recall for its Rejuvenate and ABG II modular-neck stems because of post-marketing surveillance data which suggests a potential risk of what it has termed “fretting and corrosion”.

CareFusion has issued an update following its voluntary recall of its AirLife™ Infant Breathing Circuit. The FDA has classified this action as a Class 1 recall, which means the problem constitutes a reasonable probability of serious adverse health consequences or death.

Covidien has been on the unpleasant end of FDA’s big stick, the agency having written to the company about a raft of areas in which it has found the handling of the Duet TRS stapler recall to be inadequate.