CF Delivery Dev Caps Bravo x5 Recalled for Aspiration Risk
FDA recalls CF Delivery Dev Caps Bravo x5 capsules because they may fail to attach to the esophagus, leading to aspiration.
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: The recall is classified as FDA Class II and involves reports of significant injury, including potential need for intubation and extended hospital stays, which meets the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling CF Delivery Dev Caps Bravo x5 capsules (FGS-0635/FGS 0636) manufactured by Covidien Llc. The recall involves 62,551 units that were distributed worldwide and nationwide in the United States. These devices are intended for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children aged 4 years and older.
The recall is due to a risk that the capsule may fail to attach to the esophageal mucosa. If the capsule detaches, it may be aspirated into the airway. In such cases, immediate intervention is required to remove the capsule. Potential outcomes of aspiration include low oxygen saturation, the need for intubation, extended hospital stays, and delays in treatment. The FDA has received 13 reports of capsule aspiration in the last two years.
Patients and healthcare providers should stop using the affected capsules and contact their healthcare provider for guidance on removal or replacement. Consumers should check their lot numbers against the list provided in the official recall notice to determine if their devices are affected.
The recalled product
- Product
- CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
- Manufacturer
- Covidien Llc
- Hazard
- Affected units
- 62,551
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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