FDA Recalls Devon Surgical Positioning Kits Due to Strap Separation Risk
The FDA is recalling 264 Devon Supine, Lithotomy and Trendelenburg Positioning Kits because straps may separate from the foam pad.
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 is classified as FDA Class II. The hazard involves a mechanical failure (strap separation) that could compromise patient positioning during surgery, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 264 Devon Supine, Lithotomy and Trendelenburg Positioning Kits manufactured by Covidien LLC. The recall was initiated because the straps on the device may separate from the foam pad. The device is intended to provide padding under the patient and help maintain the position of an anesthetized patient during surgery.
The affected product is identified by Product Code 31151090 and specific lot codes: 14085, 14086, 14092, 14095, 14101, and 14106. The original recall submission incorrectly listed lot codes 14084 and 14094, which were reported by the manufacturer in error. The devices were distributed nationwide in the United States, specifically in the states of New Jersey, California, Texas, Illinois, Missouri, Pennsylvania, Ohio, Indiana, Michigan, Minnesota, Florida, the District of Columbia, Virginia, Mississippi, Maine, Nevada, Arkansas, Kentucky, New York, Kansas, and South Carolina.
Healthcare facilities should stop using the affected positioning kits and contact the manufacturer for instructions on return or replacement. The FDA classifies this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.
- Manufacturer
- Covidien LLC
- Affected units
- 264
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 (7)
- 14085
- 14086
- 14092
- 14095
- 14101
- 14106 *The original recall submission listed 14084 and 14094
- these were reported by Covidien in error on the original submission.
Distribution
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