Recalls

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.

One specific LOT of Baxter’s sterile water for irrigation may be contaminated by a bacterium. As a precautionary measure the company is acting and UK’s regulatory body has issued a device alert calling for quarantining of identified product as further investigation is performed.

FDA has issued updated guidance on the clinical management of problematic Riata and Riata ST ICD leads. We take a considered look at how patients must be feeling and how well they’re getting looked after through this whole stressful experience.

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.

UK medical device regulatory authority the MHRA has issued a Medical Device Alert pertaining to the Ankle Evolutive System prosthesis from French company Transystème-JMT Implants. Evidence has been mounting for a while, which raises the question of whether regulatory oversight was adequate.

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.

Terumo Cardiovascular Systems has issued guidance regarding what to do in the event of a false air bubble detector alarm, together with some corrections to the user manual, but is not recalling the devices, nor suggesting withdrawal from use.

J&J’s Cordis division is worried that one lot of its Fire Star Rx Balloon Catheters runs the risk of deflating too slowly or worse, not at all. The recall is limited to certain Far Eastern countries.

Smith & Nephew is withdrawing a component of one of its all-metal artificial hip systems following a higher than normal level of patient problems with the device. The fact that the recall was provoked by clinical outcome data points to the potential power of implant registries in regulating surgical implants.