Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1487-2024Class II

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

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-03-05 / Open, Classified / root cause: manufacturing process

MEDLINE INDUSTRIES, LP - Northfield began a recall of Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1487-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS
Product code
QTC Adult Portable Bed Rails For Medical Purposes
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.
Root cause tag
manufacturing process
FDA root cause
Under Investigation by 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.
Quantity in commerce
2895 devices
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots
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;

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1487-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1487-2024Class IIOngoingVoluntary: Firm initiated
Z-1488-2024Class IIOngoingVoluntary: Firm initiated