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Recall Observatory FDA recall evidence

Device 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)

Z-1488-2024

March 05, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94210
Status
Ongoing
Classification
Class II
Quantity
79 devices
Official record key
device-enforcement:Z-1488-2024

Official wording

Reason: 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.

Code information: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), Lot Numbers: 15123110004, 15123110005, 15124010001, 15124020002; b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH, Lot Numbers: 15123110004, 15123110005, 15123120001

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.