Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

ES0101, AEM Disposable Curved Scissors, 1/2", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures

FDA Recall Z-2395-2011 · Posted 2011-05-31

Recalling FirmEncision, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2011-04-07
Date Terminated2011-08-09
Product Quantity574 Ten-Count Boxes, 24 Kits

Reason for Recall

Sterility may be compromised due to holes in packaging.

Firm Action

Encision, Inc. sent an Important Safety Notice letter dated April 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to either carefully inspect any remaining pouches for readily visible holes in the Tyvek pouch, or return the affected lots to Encision for inspection. Customers were also asked to fill in and fax back the attached Confirmation to 303-444-2693.

Root Cause

Package design/selection

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Australia and New Zealand

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K912780MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELDElectroscope, Inc. · 1991-12-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑