i-view Video Laryngoscope Recalled Due to Depleted Battery Risk
Intersurgical Inc is recalling the i-view video laryngoscope (Model 8008000) due to the potential for faulty devices caused by depleted batteries. A total of 2,152 affected units were distributed across the United States.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the rubric, FDA Class I recalls never score below 4. Device failure during laryngoscopy in an airway management context presents serious risk of patient harm, meeting the criteria for Severe classification.
Plain-English summary
Intersurgical Inc is recalling the i-view video laryngoscope, Model Number 8008000, which is indicated to facilitate laryngoscopy. The recall affects 2,152 units distributed across the United States.
The recall was initiated due to the potential for faulty devices as a result of depleted batteries.
Affected devices were distributed to the following U.S. states: Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Nevada, New York, Ohio, Pennsylvania, South Carolina, Texas, and Virginia. Affected lot numbers are 1240555 and 1240793. UDI-DI (Case): 05030267166497; UDI-DI (Single Unit): 5030267150649.
Healthcare facilities and practitioners using affected units should contact Intersurgical Inc immediately for replacement options and further instructions.
The recalled product
- Product
- i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
- Manufacturer
- Intersurgical Inc
- Hazard
- battery-depletion
- device-failure
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)
- 1240793.
Distribution
Distributed in 17 states:
- AZ
- CA
- FL
- GA
- IL
- IN
- KS
- MD
- MI
- MO
- NV
- NY
- OH
- PA
- SC
- TX
- VA
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