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MEDLINE INDUSTRIES, LP - Northfield recalls Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline Sw
Recalled April 17, 2024 · FDA recall Z-1488-2024 · MEDLINE INDUSTRIES, LP - Northfield
Hazard
Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable Bed Rails ) and failed to meet all mandatory requirements outlined in these standards. · FDA Class II
Units
79 devices
Sold at
Worldwide distribution - US Nationwide and the country of Canada.
Description
Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable Bed Rails ) and failed to meet all mandatory requirements outlined in these standards.
Product
Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →