Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAM
FDA device recall Z-1487-2024 · posted 2024-04-05 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- QTC
- Quantity affected
- 2895 devices
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Date initiated
- 2024-03-05
- Date posted
- 2024-04-05
- Location
- Northfield, IL
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