Medical Device Recall: Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
MEDLINE INDUSTRIES, LP - Northfield · March 5, 2024
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
States Affected
NATIONWIDE
Quantity Affected
79 devices
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1488-2024
Status: ongoing
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