Covidien Recalls Syringes Filled With Unsterilized Water

Covidien Ltd., an Irish company with U.S. headquarters in Mansfield, Mass., has begun a recall of 14 lots of its Monoject prefill flush syringes. According to the company’s notice, the syringes are filled with non-sterilized water—water not subjected to the autoclave sterilization process—which, if administered to a patient, could lead to fatal blood stream infections. These particular syringes were being sold in the United States and Bermuda.

The syringes are designed to inject saline or the anticoagulant drug heparin. The faulty products are labeled as either sodium chloride flush or heparin lock flush. Some of these syringes have the mismatched syringe tip cap, syringe label, filled volume and wrapper. However, for the sodium chloride flush syringes with matched tip cap, syringe label, filled volume and wrapper, there are no visual cues for the clinician to identify the problematic products.

Analysts from Zacks Equity Research, a financial data and analysis company, predicted that this recall “is likely to have an adverse material impact on the business, results of operations, financial conditions and cash flow” on Covidien.

In fiscal year 2012, Covidien voluntarily recalled its Duet TRS universal straight and articulating single use loading units, which resulted in an $85 million decline in net sales for the product line. It was a key endomechanical product under the company’s medical device segment. The recalls also led to the discontinuance of the product, resulting in $18 million of inventory and capital equipment impairments.

In July last year, the U.S. Food and Drug Administration (FDA) issued a Class I recall for certain lots of Shiley size 8 adult, reusable, cuffed tracheostomy tubes made by Covidien after receiving reports of product complications during mechanical ventilation. The product was a part of the airway management segment under the company’s respiratory and monitoring products business.

Then in August last year, Covidien initiated the voluntary recall of specific manufactured lots of the DGPHP radiofrequency ablation (RFA) high-power single use grounding pads and the cool-tip RFA electrode kits that included the pads. According to adverse event reported to the FDA, this device had induced four burn injuries due to the degeneration of the foil within the DGPHP grounding pad.

Zacks analysts foresee a hit to Covidien’s goodwill if any further recalls are announced, giving a boost to competitors including Becton Dickinson, C.R. Bard, and CareFusion.