Lucid Diagnostics, Inc.: Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Product Description: EsophaCap is pouched as

Hazard

The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.

Details from the source

Reason for recall: The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal. Distribution: US Nationwide distribution in the states of MN, MD. Quantity: 157 units (US) Lot/code info: Lot Code: Product Sent to Clinical Site: Part #: EC20T20VI ; GTIN Number: 00860007510953 ; Lot #'s: 462 (Qty: 25), 486 (Qty: 32), 501 (Qty:100) Product at Distributor in Quarantine: Part #: EC20T20VI ; GTIN Number: 00860007510953 ; Lot #'s: 486 (Qty: 18), 540 (Qty: 97)

UPC codes

00860007510953

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.