Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
Reason for recall: Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications. Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Bolivia (Plurinational State of), Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Indonesia, Kuwait, Mexico, Panama, Peru, Puerto Rico, Taiwan, Trinidad and Tobago, Uruguay, and Viet Nam. Quantity: 335, 448 units Lot/code info: UDI DI 150995901HEMDILUENT5R; Container Number: 0001-0401: Lot numbers: Lot Numbers Beginning with 3541: 3541500, 3541510, 3541520, 3541550, 3541610, 3541620, 3541670, 3541690, 3541750, 3541770, 3541790, 3541810, 3541830, 3541860, 3541880, 3541900, 3541910, 3541920, 3541930, 3541940, 3541950, 3541990; Lot Numbers Beginning with 3542: 3542010, 3542030, 3542050, 3542070, 3542110, 3542150, 3542170, 3542180, 3542190, 3542230, 3542250, 3542260, 3542270, 3542310, 3542350, 3542370, 3542450, 3542490, 3542510, 3542530, 3542570, 3542590, 3542610, 3542630, 3542650, 3542670, 3542720, 3542740, 3542760, 3542780, 3542800, 3542820, 3542840, 3542850, 3542900, 3542920, 3542940, 3542960, 3542980; Lot Numbers Beginning with 3543: 3543000, 3543020, 3543040, 3543050, 3543080, 3543120, 3543140, 3543160, 3543170, 3543180, 3543200, 3543220, 3543240, 3543280, 3543300, 3543320, 3543340, 3543360, 3543370, 3543390, 3543410, 3543430, 3543460, 3543480, 3543500, 3543540, 3543560, 3543580, 3543610, 3543850, 3543870, 3543890, 3543910, 3543930, 3543950, 3543970, 3543990; Lot Numbers Beginning with 3544: 3544010, 3544030, 3544040, 3544050, 3544070, 3544090, 3544110, 3544130, 3544150, 3544160, 3544170, 3544190, 3544210, 3544230, 3544250
Official record: FDA (Device enforcement) ↗
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