Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number...
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1487-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1488-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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