Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: N/A

Reason: 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.

Code information: Lot Code: Product sent out to clinical site: Part #: EC25T10VI ; GTIN Number: 00860007510977 ; Lot #'s: 483 (Qty: 120), 502 (Qty: 100) Product at Distributor in Quarantine: Part #: EC25T10VI ; GTIN Number: 00860007510977 ; Lot #'s: 539 (Qty: 99)

Distribution pattern: US Nationwide distribution in the states of MN, MD.