Z-1900-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2024
- Initiation Date
- April 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 220 units (US)
Product Description
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 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 Pattern
US Nationwide distribution in the states of MN, MD.
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)