Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
This recall is currently active, issued April 5, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- March 5, 2024
- Posted
- April 5, 2024
- Recall Number
- Z-1488-2024
- Quantity
- 79 devices
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
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
Root Cause
Under Investigation by firm
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.