Situate Gauze Recalled for Potential Failure to Detect by Console
Covidien LLC is voluntarily recalling Situate Gauze RF and X-Ray detectable products due to a manufacturing error that may prevent detection by the Situate console.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (medical device) where a failure to detect retained foreign objects could lead to injury, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Covidien LLC is voluntarily recalling Situate Gauze RF and X-Ray detectable products, specifically Product Number G0804-16P02CN-1. The recall involves 20,800 units distributed in the U.S. The affected lot number is 170704A, and the UDI is 20884521700861.
The recall is being conducted due to a manufacturing error that creates a potential for the Situate detection console to fail to detect the affected gauze products. These single-use cotton disposables are designed to be used with the Situate delivery system and feature an attached RF Tag that resonates a signal when activated by magnetic impulses from scanning devices.
Healthcare facilities and users of the Situate delivery system should stop using the affected products immediately. Users should contact the manufacturer for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device…
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Surgical Gauze
- Affected units
- 20,800
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)
- Lot Number: 170704A UDI: 20884521700861
Distribution
Distribution scope not specified by the agency.
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