Brathwaites Oliver Medical Recalls Introes Pocket Bougie Endotracheal Tube Introducers
Brathwaites Oliver Medical is recalling Introes Pocket Bougie endotracheal tube introducers because the device may break during intubation.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (device breakage) in a medical device used during a critical procedure, which poses a significant risk of injury.
Plain-English summary
Brathwaites Oliver Medical is recalling 760 units of the Introes Pocket Bougie endotracheal tube introducer, size 14 Fr (4.7mm) x 60 cm. The device is used as a guide during intubation in anesthesiology. The recall is due to a risk that the device may break during the procedure.
The affected units are identified by Model OL-E12102 and lot number 101615. The products were distributed to U.S. consignees in Illinois, Wisconsin, Oregon, New York, Utah, Indiana, Nebraska, Pennsylvania, Missouri, Ohio, Arizona, Massachusetts, Connecticut, and North Carolina, as well as to a foreign consignee in Canada.
Healthcare providers should stop using the affected devices and contact the manufacturer for instructions on how to return or dispose of them.
The recalled product
- Product
- The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.
- Manufacturer
- Brathwaites Oliver Medical
- Hazard
- Affected units
- 760
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)
- Model OL-E12102
- lot# 101615.
Distribution
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