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FDA (Device enforcement)Recalled 2024-03-05class ii

MEDLINE INDUSTRIES, LP - Northfield: Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS

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.

Details from the source

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. Quantity: 2895 devices Lot/code info: a) Medline, Model Number BA6800, Lot Numbers: 88523090002, 88523090003, 88523100001, 88523100002, 88523100003, 88523110002, 88523110003, 88523120002, 88523120003, 88524010002, 88524020001, 88524020002, 88524030001; b) Medline Martha Stewart, Model Number MDS6800BAMMS, Lot Numbers: 39323090001, 39323090002, 39323100001, 39323100002, 39323110001, 39323110002, 39323120001, 39323120002, 39324010001, 39324010002;

UPC codes

88523090002, 88523090003, 88523100001, 88523100002, 88523100003, 88523110002, 88523110003, 88523120002, 88523120003, 88524010002, 88524020001, 88524020002, 88524030001, 39323090001, 39323090002, 39323100001, 39323100002, 39323110001, 39323110002, 39323120001, 39323120002, 39324010001, 39324010002

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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