Shares of Teleflex Incorporated TFX dropped 0.58% to close at $332.80 yesterday, after the news of the global recall of certain lots of Hudson RCI Sheridan Endotracheal Tubes surfaced. The recalled products had been designed for oral or nasal intubation and were supposed to enable efficient airway management. These recalled products were distributed from October 2016 to May 2019.
More About the Product Recall
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) about an increased occurrence of specific batches of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). The immediate aftermath of this hazard for patients is disconnection from the breathing circuit, which may lead to insufficient oxygenation, thereby necessitating medical intervention.
Four cases of death and additional cases of serious injury have been reported, where ETT disconnection may have been a factor. The FDA has classified the recall of Hudson RCI Sheridan Endotracheal Tubes as a Class I recall.
Teleflex issued a statement saying consumers who own the tampered product should immediately discontinue use and return all affected products to the company or its distributor. The company has also requested consumers, experiencing any negative effects or quality issues with the use of this product, to report to the FDA’s MedWatch Adverse Event Reporting program either online, through regular mail or fax.
In the past year, the stock has improved 20.7% compared with the industry’s growth of 3%.
Teleflex 公司( Teleflex Incorporated TFX )股价昨日下跌0.58%，收于332.80美元。召回的产品是为口腔或鼻腔插管设计的，应该能够实现有效的气道管理。该等召回产品已于二零一六年十月至二零一九年五月分派。
这次自愿召回是由于报告的投诉（<0.0025%的所有范围内分布的产品）增加发生的具体批次的15毫米 Sheridan 连接器变得脱离气管（ ETT ）。这种危险对患者的直接后果是与呼吸回路断开，这可能导致氧合不足，从而需要医疗干预。
有4例死亡和其他严重损伤病例报告，其中 ETT 断开可能是一个因素。FDA 将 Hudson RCI Sheridan 气管内管的召回列为 I 级召回。
Teleflex 发表声明说，拥有被篡改产品的消费者应立即停止使用，并将所有受影响的产品归还给公司或其经销商。该公司还要求消费者在使用该产品时遇到任何负面影响或质量问题，通过定期邮件或传真在线向 FDA 的 MedWatch 不良事件报告程序报告。