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霍尼韦尔召回Fendall 2000非无菌洗眼筒

Honeywell Recalls Fendall 2000 Non-Sterile Eyewash Cartridges

RTTNews 等信源发布 2024-04-08 17:48

可切换为仅中文


Honeywell Safety Products USA, Inc., affiliated to conglomerate Honeywell International Inc., has recalled Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station, according to the U.S. Food and Drug Administration.The recall was initiated due to a lack of appropriate policies and procedures by Honeywell's supplier, which has been found to be non-compliant with current good manufacturing practice or cGMP requirements.The Fendall 2000 Non-Sterile Eyewash Cartridge is used for flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination.The impacted product is contained in a 25-liter Ethylene-vinyl acetate or EVA bag that is designed for use with the Fendall 2000 Eyewash Station.

据美国食品和药物管理局称,隶属于霍尼韦尔国际集团(Honeywell International Inc.)的霍尼韦尔安全产品美国公司(Honeywell Safety Products USA,Inc.)已召回Fendall 2000非无菌洗眼药筒,用于Fendall 2000洗眼站。此次召回是由于霍尼韦尔供应商缺乏适当的政策和程序而发起的,该政策和程序被发现不符合当前的良好生产规范或cGMP要求。Fendall 2000非无菌洗眼器用于冲洗或冲洗眼睛,以减少由酸、碱或颗粒污染引起的严重伤害的机会。受影响的产品装在25升乙烯-醋酸乙烯酯或EVA袋中,该袋专为Fendall 2000洗眼器设计。

The saline eyewash solution contains purified water, benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate diabasic, and sodium phosphate monobasic. It is not marketed as sterile.The recall includes only the Fendall 2000 refill cartridges, and no other eyewash products. The recall involves Fendall 2000 Non-Sterile Eyewash Cartridge sold in the USA with manufacturer's product number/ catalog number of 32-002050-0000, manufacturing dates of 11-Oct- 2021 through 21-Jun-2023 and expiration date of 11-Oct-2023 through 21-Jun-2025..

盐水洗眼液含有纯净水、苯扎氯铵、依地酸二钠、氯化钠、磷酸二氢钠和磷酸一钠。它不作为无菌产品销售。此次召回仅包括Fendall 2000填充墨盒,没有其他洗眼产品。此次召回涉及在美国销售的Fendall 2000非无菌洗眼药筒,制造商的产品编号/目录号为32-002050-0000,生产日期为2021年10月11日至2023年6月21日,有效期为2023年10月11日至2025年6月21日。。

About 6,954 units of the affected product were sold in the USA and about 3,651 units in Canada.The agency noted that use of or exposure to the eyewash without seeking medical attention afterwards could result in a range of ocular infections such bacterial keratitis or endophthalmitis.Immunocompromised individuals, those sustaining ocular injuries that damage the corneal epithelium, and those sustaining penetrating ocular injuries are at higher risk of potential infection.

约6954单位受影响产品在美国销售,约3651单位在加拿大销售。该机构指出,使用或接触洗眼液而不寻求医疗救助可能会导致一系列眼部感染,如细菌性角膜炎或眼内炎。免疫功能低下的个体,那些受到损害角膜上皮的眼部损伤的个体,以及那些受到穿透性眼部损伤的个体,潜在感染的风险更高。

However, Honeywell has not received any reports of adverse events related to the recall so far.Consumers are urged to immediately destroy or dispose of all units subject to the recall. For More Such Health News, visit rttnews.com For comments and feedback contact: editorial@rttnews.comBusiness News.

然而,到目前为止,霍尼韦尔尚未收到任何与召回有关的不良事件报告。消费者被敦促立即销毁或处置所有受召回影响的单元。有关更多此类健康新闻,请访问rttnews.com获取评论和反馈联系方式:editorial@rttnews.comBusiness新闻。

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