Recall Z-1488-2024— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-03-05. FDA's recall record names no specific 510(k) clearance for this event. 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). 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..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-05
- Firm location
- Northfield, IL, United States
Product description
Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.