(COV) has started recalling 6 lots of Monoject prefill flush
syringes as these syringes are filled with non-sterilized water,
which if administered could lead to fatal infections in the blood
stream. These syringes were being sold in the U.S. and Bermuda.
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The syringes, which are designed to inject saline or heparin
drug, have wrong tip cap, labeling, volume and wrapper. Moreover,
the heparin lock flush syringe with only water could clot
The announcement of the manufacturing flaws cast a negative
shadow over Covidien, a renowned producer of cutting-edge medical
devices. The recall is likely to have an adverse material impact
on the business, results of operations, financial conditions and
In fiscal 2012, Covidien had voluntarily recalled Duet TRS
Universal Straight and Articulating Single Use Loading Units
(Duet), 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.
Further, in Aug 2012, Covidien had also initiated the voluntary
recall of specific manufactured lots of the DGPHP Radiofrequency
Ablation (RFA) High-Power Single Use Grounding Pads and Cool-tip
RFA Electrode Kits that include the DGPHP RFA High-Power Single
Use Grounding Pads. According to reports, this device had induced
four burn injuries due to the degeneration of the foil within the
DGPHP grounding pad.
COV also recalled a particular model of its cuffed Shiley
tracheostomy tubes 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.
If such a trend continues and similar product recalls follow in
the future, COV's goodwill will be adversely affected. However,
this will be beneficial for its peers such as
Covidien has a Zacks Rank #3 (Hold).
(We are reissuing this article to correct a mistake. The
original article, issued Wednesday, Aug 21, 2013, should no
longer be relied upon.)