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Open, Classified

Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS

FDA Recall Z-1487-2024 · Posted 2024-04-05

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeQTC
Date Initiated2024-03-05
Product Quantity2895 devices

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.

Firm Action

Medline Industries, LP issued a Medical Device Recall Notice to its consignees on 03/05/2024 via USPS first class mail and email. The notice explained the issue with the device and requested the consignee destroy the device. Distributors were directed to notify their customers.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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