Recall Z-1899-2024
Lucid Diagnostics, Inc. · initiated April 24, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 individual units. 10 units go into a shelf-box. Component: No
Codes / lots: 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)
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.
FDA-determined cause: Under Investigation by firm
Action taken
On April 24, 2024 direct customers were sent notification letters via email with recall instructions. Effectiveness Checks: The signed Acknowledgment and Receipt forms must be returned along with any product that is still in-hand at the clinical sites. Customer Follow-up: Follow-ups will be conducted via phone and email for customers who do not respond. Returned Product: Returned product will be put into quarantine until all recalled product is under our control. Access is limited to authorized personnel only. It will then be destroyed. Destruction: Devices will be cut and disposed of. Once the string is cut, the device will no longer be functional to use. PD1 Quarantined: 115 PD2 Quarantined: 99 Preventive Action Taken by Firm: All EsophaCap product in the field will be returned to Lucid Diagnostics. The EsophaCap product is no longer manufactured for the clinical studies. The last manufactured product was February 2023.
Details
- Recall number
- Z-1899-2024
- Initiated
- April 24, 2024
- Posted by FDA
- May 24, 2024
- Product code
- EOX – Esophagoscope (Flexible Or Rigid)
- Quantity
- 157 units (US)
- Distribution
- US Nationwide distribution in the states of MN, MD.
- Recalling firm
- Lucid Diagnostics, Inc., Foxboro, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1900-2024 Class II | Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch)…The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from… | 04/24/2024Open, Classified |