Molnlycke Recalls 7x10 Inch Small Utility Positioners Due to Metal Shavings
Molnlycke Health Care is recalling 960 units of 7x10" Small Utility Positioners because they may contain metal shavings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (metal shavings) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Molnlycke Health Care, Inc. is recalling 960 units of 7x10" Small Utility Positioners with Cover. The recall is being conducted because the products may not meet specifications due to the possible presence of metal shavings.
The affected products were distributed domestically to Arkansas, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New York, Ohio, Texas, Virginia, and Wisconsin. The products are identified by Recorder Code 1400227.
Consumers and healthcare facilities should stop using the affected products and contact Molnlycke Health Care for further instructions.
The recalled product
- Product
- 7x10" Small Utility Positioner with Cover
- Manufacturer
- Molnlycke Health Care, Inc
- Affected units
- 960
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Recorder Code 1400227
Distribution
Part of a larger recall action
This product is one of 2 recalled by Molnlycke Health Care, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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