Teleflex Medical Recalls Green Rusch Laryngoscope Blades for Labeling Inconsistency
Teleflex Medical is recalling 6,200 Green Rusch laryngoscope blades due to a labeling inconsistency. The devices were distributed nationwide.
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 and involves a labeling inconsistency without reported injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Teleflex Medical is recalling 6,200 units of the Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade. The recall is due to a labeling inconsistency. The product is used to visualize the upper airway and aid in the placement of a tracheal tube.
The affected products are identified by Product Code 004551004 and Lot 1305342. The devices were distributed nationwide to facilities in 31 states, including Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, and Wisconsin.
Healthcare facilities should stop using the affected products and contact Teleflex Medical for instructions on how to return them. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube.
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Laryngoscope
- Hazard
- Affected units
- 6,200
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 (2)
- Product Code 004551004
- Lot 1305342
Distribution
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