Reported Apr 7, 2021 · Ongoing
CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - 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?
- CF Delivery Dev Caps Bravo x5
- FGS-0635/FGS 0636 - 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
144 of 144 codes
46966F47358F47359F47360F47361F47362F47363F47364F47365F47366F47367F47368F47369F47370F47371F47783F48082F48083F48084F48085F48086F48087F48088F48090F48091F48092F48437F48438F48439F48440F48441F48442F48443F48444F48445F48446F48447F48448F48449F48781F48782F48783F49068F49069F49070F49071F49072F49073F49074F49075F49076F49077F49078F49079F49080F49081F49082F49083F49084F49366F
- Amount recalled
- 62,551
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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