Reported Apr 7, 2021 · Ongoing
BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH…
Covidien LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien Llc · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
- BRAVO PH CAPS DELIVERY DEV5-PK
- FGS-0312/FGS-0313 - Product Usageintended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age
- Lot codes and dates
49349Q49350Q49351Q49352Q49799Q49800Q49801Q49802Q49809Q49849Q49850Q49851Q50392Q50393Q50492Q50493Q50494Q50495Q50496Q50497Q50615Q50616Q50868Q50869Q50870Q50871Q50872Q50873Q50874Q50875Q50876Q50877Q50878Q50879Q50880Q50881Q
- Amount recalled
- 62551
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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