Invuity Recalls Obsolete BriteField Illuminated Suction Devices
Invuity is recalling 197 obsolete BriteField Illuminated Suction Devices nationwide. The devices were not distributed after March 2011.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text indicates the devices are obsolete and have not been distributed since March 2011, suggesting a voluntary precautionary recall without reported injuries or illnesses.
Plain-English summary
Invuity, Inc. is recalling 197 obsolete BriteField Illuminated Suction Devices. The affected products include model numbers 8Fr, 10Fr, and 12Fr, which were sold in kits containing a sterilization tray. These devices are intended to aspirate from the surgical site and provide illumination from a high-intensity light source.
The recall covers devices distributed nationwide, including in Arkansas, Georgia, South Carolina, California, Oregon, Utah, and Washington. Invuity states that the devices have not been distributed since March 2011, as the next generation product was introduced at that time.
Customers are notified to return all obsolete BriteField Illuminated Suction Devices from the field. Specific catalog and lot numbers are listed in the official recall documentation.
The recalled product
- Product
- BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high…
- Manufacturer
- Invuity, Inc.
- Hazard
- Affected units
- 197
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 (20)
- Catalog numbers: 1810000
- 1811273
- 1811873
- 1810873
- 18111073 All possible lot numbers: 8Fr: 09061802
- 09070201
- 09101602
- 09120701
- 10022602
- 10030801
- 10060102
- 10Fr: 09061801
- 09070202
- 09120702
- 09101603
- 10022603
- 10030802
- 10060905
- 10060904
- 10060103
Distribution
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